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Post-marketing study of gabapentin enacarbil to evaluate the effect in restless leg syndrome (RLS) patients with moderate renal impairment

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01981941

Astellas Study ID

The unique identification code given by the study sponsor.

8825-CL-0103

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

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Condition

Restless Legs Syndrome

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

20 years - 80 years

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Nov 2013 - May 2015

Masking

None (Open Label)

Enrollment number

19

Post-marketing clinical study of gabapentin enacarbil ―Non-blinded study in restless legs syndrome (RLS) patients with moderate renal impairment―

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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