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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657514
Recruitment Status : Withdrawn (Insufficient enrollment)
First Posted : April 14, 2008
Last Update Posted : August 15, 2014
Information provided by (Responsible Party):
Mark Nehler, MD, Colorado Prevention Center

Brief 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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Angina Drug: Ranolazine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Ranolazine on Skeletal Muscle Endpoints During Exercise In Subjects With Chronic Angina and Peripheral Arterial Disease
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arm Intervention/treatment
Active Comparator: A
Drug arm - 500mg tablet po bid up to 1000mg (2 500mg tablets) po bid
Drug: Ranolazine
500mg tablet po bid up to 1000mg (2 500mg tablets) po bid
Other Names:
  • Ranexa, extended-release tablets
  • CVT500
  • light orange
  • NDC Code: 67159-112-04

Placebo Comparator: P
Placebo arm - 1 tablet po bid up to 2 tablets po bid if tolerated
Drug: Placebo
1 tablet po bid up to 2 tablets po bid if tolerated

Primary Outcome Measures :
  1. skeletal muscle hemoglobin desaturation kinetics [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. peak exercise oxygen consumption [ Time Frame: 6 weeks ]
  2. Pulmonary oxygen uptake on-kinetics [ Time Frame: 6 weeks ]
  3. Steady state level of tissue hemoglobin desaturation during exercise [ Time Frame: 6 weeks ]
  4. Recovery kinetics of tissue oxygen saturation following exercise [ Time Frame: 6 weeks ]
  5. adverse events [ Time Frame: 6 weeks ]
  6. Peak Walking Time (PWT) [ Time Frame: 6 weeks ]
  7. Claudication Onset Time (COT) [ Time Frame: 6 weeks ]
  8. Time to Onset of Angina (TOA) [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00657514

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United States, Colorado
University of Colorado at Denver
Aurora, Colorado, United States, 80045
Denver Health and Hospital Authority (DHHA)
Denver, Colorado, United States, 80204
Department of Veteran Affairs Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
Colorado Prevention Center
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Principal Investigator: Mark R Nehler, MD The Univesity of Colorado at Denver
Study Chair: William R Hiatt, MD Colorado Prevention Center
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Responsible Party: Mark Nehler, MD, Chief, Section of Vascular Surgery and EndoVascular Therapy and Podiatry, Colorado Prevention Center Identifier: NCT00657514    
Other Study ID Numbers: 07-PAD-01
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by Mark Nehler, MD, Colorado Prevention Center:
hemoglobin desaturation kinetics
peripheral arterial disease
chronic angina
exercise tolerance
Additional relevant MeSH terms:
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Angina Pectoris
Peripheral Arterial Disease
Peripheral Vascular Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Arterial Occlusive Diseases
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action