Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities

NCT00914316 | Terminated Results DMC

• 1 other identifier: 2009-051
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate whether supervised treadmill exercise combined with ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance over supervised exercise alone in patients with stable claudication. Investigators also seek to determine if the administration of ranolazine provides a sustained benefit after the completion of a supervised exercise regimen. Lastly, investigators wish to determine whether both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in patients with stable claudication.

Conditions

Peripheral Arterial Disease

Keywords

Lower leg claudication; Poor circulation of the leg muscles; Cramping or discomfort in the lower legs; Lower leg pain; PAD (Peripheral arterial disease)

Outcome Measures

Primary Outcomes (1)

• Percentage Increase in Absolute Walking Distance Following Phase 1

  Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test

  12 weeks

Secondary Outcomes (1)

• Percentage Increase in Absolute Walking Distance Following Phase 2

  24 weeks

Study Arms (4)

Phase 1-Ranolazine, Phase 2-Ranolazine

ACTIVE COMPARATOR

This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.

Drug: Ranolazine

Phase 1 -Ranolazine, Phase 2 -Placebo

ACTIVE COMPARATOR

This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.

Drug: Ranolazine; Drug: Placebo

Phase 1 -Placebo, Phase 2 -Ranolazine

ACTIVE COMPARATOR

This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.

Drug: Ranolazine; Drug: Placebo

Phase 1 -Placebo, Phase 2 -Placebo

PLACEBO COMPARATOR

This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.

Drug: Placebo

Interventions

Ranolazine DRUG

Ranolazine, 1000 mg, capsule, twice daily, by mouth.

Also known as: Ranexa

Phase 1 -Placebo, Phase 2 -Ranolazine; Phase 1 -Ranolazine, Phase 2 -Placebo; Phase 1-Ranolazine, Phase 2-Ranolazine

Placebo DRUG

twice daily

Also known as: sugar pill

Phase 1 -Placebo, Phase 2 -Placebo; Phase 1 -Placebo, Phase 2 -Ranolazine; Phase 1 -Ranolazine, Phase 2 -Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females greater than 40 years of age.
• Documented peripheral arterial disease
• Stable lower extremity intermittent claudication (Rutherford class 1-3) for 3 months.

You may not qualify if:

• Critical limb ischemia (Rutherford class 4-6).
• Percutaneous or surgical lower extremity revascularization within last 12 months.
• Myocardial infarction within the last 6 months.
• cardiac surgery within the last 6 months.
• Unstable angina
• Stable chronic angina
• New York Heart Association Class II-IV heart failure
• Left ventricular ejection fraction less than or equal to 35%
• Venous thromboembolism within the last 6 months.
• Uncontrolled high blood pressure, defined as systolic blood pressure greater than or equal to 180 mmHg or diastolic blood pressure greater than or equal to 110 mmHg.
• Allergy to ranolazine.
• corrected QT interval (QTc) greater than or equal to 440 ms in males or 460 ms in females.
• Pregnant or nursing females.
• Chronic dialysis therapy.
• Significant liver impairment (defined as transaminases greater than or equal to 3 times the upper limit of normal) within the last 6 months.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Spasm

Interventions

Ranolazine; Sugars

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Limitations and Caveats

Early termination due to recruitment and retention difficulties, leading to small numbers of subjects. Missing data for several subjects.

Results Point of Contact

• Title: Barbara Higgins, RN
• Organization: William Beaumont Hospital

Barbara.Higgins@beaumont.org

248 551-1535

Study Officials

• Laura Franny, M.D.

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: August 9, 2017
• Results First Posted: August 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)