A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of BMS-207940, a Selective Endothelina Receptor, Antangonist, in Subjects with Intermittent Claudicatio

Not Applicable

• Conditions: -I739 Peripheral vascular disease, unspecified; Peripheral vascular disease, unspecified; I739

• Registration Number: PER-033-00
• Lead Sponsor: BRISTOL MYERS SQUIBB PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-06-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Give written consent.
• Age> 40 years.
• Men, and women who are not breastfeeding, or are not pregnant, and whether they are postmenopausal (ie, not menstruating> 12 months) or surgically sterile.
• History of intermittent claudication> 6 months (stage il de Fontaine
• Index of supine pressure in ankle / brachial rest (ABl) in at least one leg between 0.4 and 0.9, with an ABI> 0.4 in at least one artery in both legs.
• Decrease of> 20 mmHg in the supine SBP in the ankle either in the posterior tibial artery or back of the foot in at least one leg measured in the first 2 minutes after suspending the treadmill selection test.
• There will also be an initial selection test <5 minutes on the treadmill. If the patient stops performing the exercise before 5 minutes have passed, the claudication should be the reason for the suspension. Patients who develop chest pain during the screening test will be disqualified from their future participation

Exclusion Criteria

• The presence of one or more clinical reactions other than claudication, for example, angina, myocardial ischemia due to ECG, shortness of breath, arrhythmia, arthritis, which limits or requires the suspension of the selection or qualification test on the treadmill.
• Revascularization in the lower extremities, percutaneous transcutaneous angioplasty, or sympathectomy in 3 months before entering the study.
• Ischemic pain at rest and / or tissue damage induced by ischemia (eg, ulceration and / or gangrene) in some affected limb.
• Leg pain during walking caused by a non-aerosolized disease, for example, arthritis or peripheral neuropathy that interferes with the perception of pain.
• Current participation or intention to enroll in a supervised physical training program.
• myocardial infarction (MI) or unstable angina, coronary artery bypass graft, PTCA and / or stents in the 3 months prior to entry into the study.
• Severe heart failure (Functional Class III or IV of the New York Heart Association).
• Persistent uncontrolled hypertension (sat blood pressure> 95 mmHg and / or sitting systolic blood pressure> 180 mmHg) or symptomatic hypotension or sitting systolic blood pressure <90 mmHg.
• Diabetes Mellitus not controlled.
• Clinically significant renal or hepatic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Walk Impairment Questionnaire (WIQ), the ratio of the posterior systolic blood pressure of the tibia and dorsal foot at rest (ankle) to the brachial blood pressure, tests on the treadmill<br>Measure:Efficacy<br>Timepoints:At the end of Weeks 4, 8, and 12 (minimum) and at the end of Week 10 (maximum)<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Descriptive summary of the different categories of<br>Adverse reactions by treatment group. The marked laboratory abnormalities will also be summarized descriptively.<br>Measure:Safety<br>Timepoints:The duration of the study<br>