Study Details

Renal Impairment study with ASP1941

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.
NCT01302028

Astellas Study ID

The unique identification code given by the study sponsor.

1941-CL-0064

EudraCT ID

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

2009-011320-61

Condition

Adult Onset Diabetes

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

45 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

Jan 2010 - Jun 2010

Masking

None (Open Label)

Enrollment number

40

An open-label, parallel group study to assess the effect of different grades of renal impairment in patients with Type 2 Diabetes Mellitus on the pharmacokinetics, pharmacodynamics and safety & tolerability of ASP1941 relative to Type 2 Diabetes Mellitus with normal renal function and healthy volunteers

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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