A randomized, double-blind, placebo-controlled, parallel group trial of HMR1766 assessing the efficacy and safety of 3 doses of HMR1766 (25, 100, 200 mg OD) versus placebo with cilostazol, 100 mg BID as a calibrator, administered for 26 weeks in patients with Peripheral Arterial Disease (PAD) Fontaine stage II. - ACCELA

sanofi-aventis recherche & développement0 sites550 target enrollmentJanuary 11, 2007

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Peripheral Arterial Disease (PAD) Fontaine stage II (intermittent claudication)
Sponsor: sanofi-aventis recherche & développement
Enrollment: 550
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

January 11, 2007

End Date

October 8, 2008

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Inclusion criteria at screening period
•Diagnosis of intermittent claudication (PAD Fontaine stage II):
•1\. Patient with stable symptoms of intermittent claudication of the lower extremities, secondary to chronic occlusive arterial disease from atherosclerosis etiology (symptoms present for 6 months or longer and not significantly changed within the past 3 months);
•2\. ICD (Initial claudication distance) of 30 to 250 m at screening constant workload treadmill test.
•Confirmation of underlying PAD:
•3\. Ankle/Brachial Index (ABI) of 0\.90 to 0\.5 or for patients with an ABI greater than 1\.3 (due to non\-compressible arteries), a Toe\-Brachial Index (TBI) of less than 0\.7\.
•Inclusion criteria at randomization
•Confirmation of symptom stability:
•4\. Mean ICD of 30 to 250 m calculated by averaging the constant workload treadmill test performed at the end of the run\-in phase and the previous one performed at screening.
•5\. The maximum change (measured in log) in the claudication distance should not exceed 0\.25 between those two ICD measurements, as per international recommendation.

•Exclusion criteria at screening / randomization visits
•1\. Patient not having provided written informed consent.
•2\. Patient participated in investigational clinical trials in the last 2 months prior screening.
•3\. Pregnant or breast\-feeding woman or woman without documented birth control measures for at least 3 months prior to randomization.
•Potentially non\-atherosclerotic and/or severe stage disease not amenable to medical therapy:
•4\. Age below 40 years and/or onset of symptoms of PAD before the age of 40 years.
•5\. Non\-atherosclerotic peripheral arteriopathy (e.g. Buerger’s disease, aneurismal states, popliteal entrapment syndrome).
•6\. Acute peripheral ischemia e.g. thrombosis in situ, trauma, paradoxical embolism of venous thrombi.
•7\. Critical limb ischemia (equivalent to Fontaine stages III and IV), manifested by ischemic rest pain or trophic lesions.
•Recent (within 3 months prior to screening) pharmacological treatment likely to interfere with study endpoints: