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Ranolazine Versus Placebo Effects on Exercise Tolerance in Patients With Heart Disease and Peripheral Arterial Disease

WithdrawnPhase 4NCT00657514
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

After 6 weeks of maximal Ranolazine therapy, tissue hemoglobin desaturation kinetics will change compared to placebo in patients with chronic angina and peripheral arterial disease.

Study details

Official title
Evaluation of Ranolazine on Skeletal Muscle Endpoints During Exercise In Subjects With Chronic Angina and Peripheral Arterial Disease
Sponsor
Colorado Prevention Center
Start date
2008-05
Primary completion
2009-06
Sex
Male
Age range
from 40 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
3

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Males age \> 40 years. * Subjects must have chronic stable angina, meeting the labeled indications for ranolazine: Ranolazine is indicated for the treatment of chronic angina. Ranolazine should be reserved for subjects who have not achieved an adequate response with other anti-anginal drugs. * Subjects must have a resting ankle brachial index (ABI) of \< 0.90 with a post-exercise decrement of ≥ 10% in at least one leg, OR a resting ABI of ≥0.90 to ≤ 1.00 with a post-exercise decrement of ≥ 20% in at least one leg * The subject has provided written informed consent to participate, understands the requirements of the study, and agrees to return for the required assessments Exclusion Criteria: * Non-atherosclerotic diseases of the peripheral circulation by clinical history * Unable to complete the first stage of the modified, extended Astrand treadmill protocol * Clinically significant ECG abnormalities or changes with exercise on the screening ECG * Evidence of critical limb ischemia (CLI) * Hepatic impairment (Child-Pugh Classes A \[mild\], B \[moderate\], or C \[severe\]) * End stage renal disease requiring dialysis * Hemoglobin \< 12 mg/dL. * Platelet count \< 90,000/mL. * Planned surgical/endovascular intervention for coronary artery disease (CAD) or peripheral arterial disease (PAD) in the next 3 months * Maximal exercise is limited by symptoms other than claudication or angina * Significant mental illness or drug abuse within 30 days of enrollment that in the opinion of the Investigator could impact the subject's ability to successfully complete the trial * Known allergy to ranolazine * Pre-existing QTc prolongation on a resting electrocardiogram (ECG) at Screening due to the risk of worsening of this condition with the use of ranolazine * Treatment with QT prolonging drugs such as Class IA (e.g. quinidine) and Class III (e.g. sotalol, dofetilide), antiarrhythmics, amiodarone, and antipsychotics (e.g. thioridazine, ziprasidone) * Treatment with potent or moderately potent CYP3A inhibitors including ketoconazole and other azole antifungals, diltiazem, verapamil, macrolide antibiotics, cyclosporine, or human immunodeficiency virus (HIV) protease inhibitors * The subject has previously received ranolazine within the 6-months prior to enrollment * The subject has received an investigational drug within 90 days prior to enrollment * Type 1 or type 2 diabetes mellitus * Congestive Heart Failure, ≥ New York Heart Association (NYHA) Class…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00657514