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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development.  Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared.  Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Participants received fezolinetant matching placebo capsules orally, BID for a period of 12 weeks.

Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.

Participants received fezolinetant 30 mg capsules orally, BID for a period of 12 weeks.

Participants received fezolinetant 60 mg capsules orally, BID for a period of 12 weeks.

Participants received fezolinetant 90 mg capsules orally, BID for a period of 12 weeks.

Participants received fezolinetant 30 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.

Participants received fezolinetant 60 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.

Participants received fezolinetant 120 mg capsules orally, QD and matching placebo QD for a period of 12 weeks.

Redacted CSR Synopsis_English

PLS_English-ESN364_HF_205.docx

Redacted Protocol for Ct.gov Results

Redacted SAP for CT.gov Results

This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.

A dose-ranging study of the efficacy of ESN364 in postmenopausal women suffering vasomotor symptoms (hot flashes)

This was a 12-week randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, multi-center study to assess the efficacy of ESN364 in postmenopausal women suffering from vasomotor symptoms (hot flashes). 
This study consisted of a screening period (Days -35 to -1, including the screening visit [Visit 1] and a minimum 7-day collection of baseline vasomotor symptom frequency and severity assessments), a 12 week treatment period (Day 1 [Visit 2] to Week 12 [Visit 5]), and a follow up visit (Week 15 [Visit 6]) 3 weeks after the last dose of study drug.  
The study was performed on an ambulatory basis. 
The screening visit (Visit 1) occurred up to 35 days prior to randomization. Eligibility was assessed via physical examination, clinical laboratory testing, vital signs, ECG, Pap smear, mammography, and endometrial biopsy. Subjects received an electronic diary to record daily vasomotor symptoms during the duration of the screening period. Subjects who had ≥7 consecutive days of vasomotor symptom recordings participated in the study. Subjects are encouraged to continue recording for the duration of the whole screening period. The electronic diary was reviewed by study site staff on Day 1 (Visit 2) to confirm study eligibility. Subjects were rescreened 1 time upon approval of the medical monitor.
During the treatment period, subjects returned to the study site every 4 weeks for assessments. 
The follow-up visit occurred approximately 3 weeks following the last dose of study drug.

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Link to plain language summary of the study on the Trial Results Summaries website.

Link to results and other applicable study documents on the Astellas Clinical Trials website.

Research Site

Research Site 058

Research Site 052

A Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging, Phase 2b Study to Investigate the Efficacy of ESN364 in Postmenopausal Women Suffering from Vasomotor Symptoms (Hot Flashes)

Frequency of moderate or severe VMS events will be calculated as the sum of moderate and severe VMS events per day.

The severity of moderate or severe VMS events will be calculated using a weighted average of VMS events.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. Baseline was the average frequency of 24 h vasomotor symptom from 7 non-missing days prior to day 1.

Frequency of Moderate and Severe Vasomotor Symptoms per 24h

The full analysis set (FAS) consisted of all randomized participants who received at least 1 dose of study drug and had baseline and at least one postbaseline efficacy evaluation.

Study Specific Characteristic

Severity of moderate to severe VMS per day was calculated as follows:
[(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS. Higher score indicates greater severity. Baseline was the average severity of 24h vasomotor symptom from 7 non-missing days prior to Day 1.

Severity of Moderate and Severe Vasomotor Symptoms per 24h

The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. Baseline was the average frequency of 24 h vasomotor symptom from 7 non-missing days prior to day 1.

Frequency of Mild, Moderate, and Severe Vasomotor Symptoms per 24h

Severity of mild, moderate and severe VMS per day was calculated as follows:
[(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)]/ number of daily mild/moderate/severe VMS. Higher score indicates greater severity. Baseline was the average severity of 24h vasomotor symptom from 7 non-missing days prior to Day 1.

Severity of Mild, Moderate, and Severe Vasomotor Symptoms per 24h

The safety analysis set (SAF) consisted of all randomized participants who received at least 1 dose of study drug.

The frequency of moderate to severe VMS was the number of moderate to severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

FAS population with available data at specified time point.

Co-Primary Efficacy Endpoint: Change From Baseline (CFB) in The Mean Frequency of Moderate to Severe Vasomotor Symptoms (VMS) at Week 4

Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 12

Severity of moderate to severe VMS per day was calculated as follows:
[(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS.
Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity.

Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 4

Severity of moderate to severe VMS per day was calculated as follows:
[(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS.

Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).
Severity was zero for participants that had no moderate or severe VMS. Higher scores indicates greater severity.

Co-Primary Efficacy Endpoint: Change From Baseline in The Mean Severity of Moderate to Severe VMS at Week 12

Week 1

Week 2

Week 3

Week 4

Week 5

Week 6

Week 7

Week 8

Week 9

Week 10

Week 11

Week 12

Week 13

Week 14

Week 15

The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, subject does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

Change from Baseline in The Mean Frequency of Mild, Moderate, and Severe VMS to Each Study Week

Change From Baseline in The Mean Frequency of Moderate and Severe VMS to Each Study Week

Severity of mild, moderate & severe VMS per day was calculated as follows

[(number of mild VMS × 1) + (number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily mild/moderate/severe VMS

Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot & was sweating & needed to take action Severity was zero for participants that had no moderate or severe VMS. Higher score indicates greater severity.

Change From Baseline in The Mean Severity of Mild, Moderate, and Severe VMS to Each Study Week

Severity of moderate to severe VMS per day was calculated as follows:

[(number of moderate VMS × 2) + (number of severe VMS × 3)]/number of daily moderate/severe VMS.

Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Severity was zero for patients that had no moderate or severe VMS. Higher score indicates greater severity.

Change From Baseline in The Mean Severity of Moderate and Severe VMS to Each Study Week

The hot flash score per 24h (or 12 h day time or 12 h night time) of VMS (mild, moderate, and severe) is calculated as follows: 

(number of mild VMS x 1) + (number of moderate VMS x 2) + (number of severe VMS x 3).

Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant did not wake up but later noticed damp sheets or clothing.
Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). Higher score indicates greater severity.

Change From Baseline in The Hot Flash Score of Mild, Moderate, and Severe VMS to Each Study Week

The hot flash score per 24h of moderate and severe VMS is calculated as follows:
(number of moderate VMS x 2) + (number of severe VMS x 3).

Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed). VMS. Baseline is the average frequency of 24h vasomotor symptom from 7 non-missing days prior to Day 1. Higher score indicates greater severity.

Change From Baseline in The Hot Flash Score of Moderate and Severe VMS to Each Study Week

Mean Percent Reduction of Mild, Moderate, And Severe Vasomotor Symptoms From Baseline to Each Study Week

Mean Percent Reduction of Moderate And Severe Vasomotor Symptoms From Baseline to Each Study Week

The frequency of mild, moderate and severe VMS was the number of mild, moderate and severe VMS per 24 hours. A daily frequency and severity per week was derived by taking the mean of the data over 7 days. Mild VMS was defined as sensation of heat without sweating/dampness. If at night, participant does not wake up but later notices damp sheets or clothing. Moderate VMS was defined as sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets. Severe VMS was defined as sensation of intense heat with sweating, caused disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., remove layers of clothes, open the window, or get out of bed).

Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week

Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week

Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week

Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Mild, Moderate, and Severe VMS From Baseline to Each Study Week

Number of Participants With Mean Percent Reduction of 50% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week

Number of Participants With Mean Percent Reduction of 70% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week

Number of Participants With Mean Percent Reduction of 90% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week

Number of Participants With Mean Percent Reduction of 100% in The Mean Frequency of Moderate and Severe Vasomotor Symptoms From Baseline to Each Study Week

Number of Participants With Absolute Reduction of 2 in Mean Number of Mild, Moderate and Severe VMS per day From Baseline to Each Study Week

Number of Participants With Absolute Reduction of 3 in Mean Number of Mild, Moderate and Severe VMS per day From Baseline to Each Study Week

Number of Participants With Absolute Reduction of 4 in Mean Number of Mild, Moderate and Severe VMS per day From Baseline to Each Study Week

Number of Participants With Absolute Reduction of 5 in Mean Number of Mild, Moderate and Severe VMS per day From Baseline to Each Study Week

Number of Participants With Absolute Reduction of 2 in Mean Number of Moderate and Severe VMS per day From Baseline to Each Study Week

Number of Participants With Absolute Reduction of 3 in Mean Number of Moderate and Severe VMS per day From Baseline to Each Study Week

Number of Participants With Absolute Reduction of 4 in Mean Number of Moderate and Severe VMS per day From Baseline to Each Study Week

Number of Participants With Absolute Reduction of 5 in Mean Number of Moderate and Severe VMS per day From Baseline to Each Study Week

The HFRDIS is a 10-item scale that measures a woman’s perceptions of the degree to which VMS interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, and enjoying life); the tenth item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory, which assess the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which VMS had interfered with each item during the previous 2-week time interval using a 0 (do not interfere) to 10 (completely interfere) scale. Overall mean score is the average of individual item scores (sum of items/10).

Change From Baseline in Hot Flash-Related Daily Interference Scale (HFRDIS) at Weeks 4, 8, 12, and 15

Week 4: Ease of Getting to Sleep

Week 4: Quality of Sleep

Week 4: Ease of Awaking From Sleep

Week 4: Integrity of Behavior Following Awaking

Week 8:Ease of Getting to Sleep

Week 8: Quality of Sleep

Week 8:Ease of Awaking From Sleep

Week 8: Integrity of Behavior Following Awake

Wek 12: Ease of Getting Sleep

Week 12: Quality of Sleep

Week 12: Ease of Awaking From Sleep

Week 12: Integrity of Behavior Following Awaking

Wek 15:Ease of Getting Sleep

Week 15: Quality of Sleep

Week 15: Ease of Awaking From Sleep

Week 15: Integrity of Behavior Following Awaking

The LSEQ is a 10-item self-rated questionnaire that assesses a participants aspects of sleep and early morning behavior. The questions are grouped into 4 chronological areas: ease of getting to sleep, perceived quality of sleep, ease of awaking from sleep, and integrity of early morning behavior following wakefulness. The LSEQ is a visual analog scale that requires respondents to place marks on a group of 10 cm lines. Lines extend between extremes like “more difficult than usual” and “easier than usual.” Responses are measured using a 100 mm scale and are averaged to a score for each domain. Higher scores indicates better sleep and better early morning behavior.

Week 4: Integrity of Behavior following Awaking

Week 8: Integrity of Behavior Following Awaking

Leeds Sleep Evaluation Questionnaire (LSEQ) Domain Scores at Weeks 4, 8, 12 and 15

Week 4: Psychological Symptoms

Week 4: Physical Symptoms

Week 4: VasomotorSymptoms Score

Week 4: Sexual Dysfunction Score

Week 4: Total Score

Week 8: Psychological Symptoms

Week 8: Physical Symptoms

Week 8: VasomotorSymptoms Score

Week 8: Sexual Dysfunction Score

Week 8: Total Score

Week 12: Psychological Symptoms

Week 12: Physical Symptoms Score

Week 12: Vasomotor Symptoms Score

Week 12: Sexual Dysfunction Score

Week 12: Total Score

Week 15: Psychological Symptoms Score
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Week 15: Physical Symptoms Score

Week 15: Vasomotor Symptoms Score

Week 15: Sexual Dysfunction Score

Week 15: Total Score

The GCS is a 21-item scale that provides a brief but comprehensive and valid measure of climacteric symptomatology. Each item is rated by the participant according to its severity using a 4-point rating scale from 0 (none) to 3 (severe). The first 20 items of the scale combine into 3 main independent symptom measures by summing up the individual item scores: psychological symptoms (items 1 to 11; score 0 to 33), physical symptoms (items 12 to 18; score 0 to 21), and VMS (items 19 to 20; score 0 to 6). Item 21 is a probe for sexual dysfunction. The total score can range from 0 to 63. Higher scores indicate worse symptoms.

Change From Baseline in Greene Climacteric Scale (GCS) at Weeks 4, 8, 12, and 15

Week 4: Vasomotor Mean Score

Week 4:Psychological Mean Score

The MENQoL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of 1 of 4 domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1 to 3), psychosocial (items 4 to 10), physical (items 11 to 26), and sexual (items 27 to 29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a 0 (not bothersome) to 6 (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain’s items by the number of items within that domain. Non-endorsement of an item is scored a “1” and endorsement a “2,” plus the number of the particular rating, so that the possible score on any item ranges from 1 to 8. Higher scores indicate that menopause symptoms are more bothersome.