Trials / Completed
CompletedNCT00443287
Efficacy and Safety of HMR1766 in Patients With Fontaine Stage II Peripheral Arterial Disease
A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of HMR1766 Assessing the Efficacy and Safety of 3 Doses of HMR1766 Versus Placebo With Cilostazol as a Calibrator, Administered for 26 Weeks in Patients With Peripheral Arterial Disease (PAD) Fontaine Stage II
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 553 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to investigate in patients suffering from intermittent claudication due to Fontaine stage II Peripheral Arterial Disease (PAD) whether a 26-week treatment by HMR1766 on top of clopidogrel may result in an improvement of walking capacity, by comparing three doses of HMR1766 to placebo, and calibrating such effect versus cilostazol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ataciguat (HMR1766) | oral administration |
| DRUG | placebo | oral administration |
| DRUG | cilostazol | oral administration |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2008-10-01
- Completion
- 2008-10-01
- First posted
- 2007-03-05
- Last updated
- 2018-05-17
Locations
7 sites across 7 countries: United States, Austria, Canada, France, Poland, Russia, South Africa
Source: ClinicalTrials.gov record NCT00443287. Inclusion in this directory is not an endorsement.