Overview

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

Status:
Withdrawn
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Colorado Prevention Center
Treatments:
Ranolazine
Criteria
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 III

- History of oxygen dependent Chronic Obstructive Pulmonary Disease (COPD)

- Body Mass Index (BMI) >35