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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.
The treatment groups are:
A. Group A will be randomized to a 12 week supervised exercise program and ranolazine, (Ranexa) 1000 mg orally, twice daily, by mouth.
B. Group B will be randomized to a 12 week supervised exercise program and placebo.
After the 12 week supervised exercise program, all participants will undergo a second randomization to ranolazine or placebo for an additional 12 weeks, during which independent walking will be encouraged.
Both groups will participate in a two week lead-in period after each randomization of the trial, allowing for the stabilization of their medications and dosing of ranolazine. Medications such as cilostazol, calcium channel blockers and nitrates will be discontinued during the lead-in period, unless their use is for management for high blood pressure. Anti-platelet (blood thinner) medications will be continued throughout the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine, 1000 mg, capsule, twice daily, by mouth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Increase in Absolute Walking Distance Following Phase 2 | Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Franny, M.D. | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
No plan to share individual participant data
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1-Ranolazine, Phase 2-Ranolazine | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. |
| FG001 | Phase 1 -Ranolazine, Phase 2 -Placebo | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. Placebo: twice daily |
| FG002 | Phase 1 -Placebo, Phase 2 -Ranolazine | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. Placebo: twice daily |
| FG003 | Phase 1 -Placebo, Phase 2 -Placebo | 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. Placebo: twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 |
|
| ||||||||||||||||||
| Phase 2 |
|
Missing data for 4 participants in Ranolazine/Ranolazine group, and 2 participants in placebo/Ranolazine group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1-Ranolazine, Phase 2-Ranolazine | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Missing data for 12 week test in 1 subject in Ranolazine/Ranolazine group, 1 subject in Ranolazine/placebo group, and 3 subjects in placebo/placebo group | Posted | Median | Inter-Quartile Range | percentage of baseline | 12 weeks |
|
28 weeks
Only 8 adverse events were collected: death, unstable angina, ischemic ST depression > 2 mm during exercise training, myocardial infarction, cerebrovascular accident, ventricular arrhythmias (non-sustained ventricular tachycardia (VT), sustained VT, ventricular fibrillation), advanced heart block (Mobitz II or Type III heart block), and congestive heart failure (CHF) requiring hospitalization.
Adverse events were collected for the 20 patients completing at least baseline testing in Phase 1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1-Ranolazine, Phase 2-Ranolazine | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
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Early termination due to recruitment and retention difficulties, leading to small numbers of subjects. Missing data for several subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Higgins, RN | William Beaumont Hospital | 248 551-1535 | Barbara.Higgins@beaumont.org |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| Placebo | Drug | twice daily |
|
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Phase 1 -Ranolazine, Phase 2 -Placebo | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. Placebo: twice daily |
| BG002 | Phase 1 -Placebo, Phase 2 -Ranolazine | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. Placebo: twice daily |
| BG003 | Phase 1 -Placebo, Phase 2 -Placebo | 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. Placebo: twice daily |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Phase 1 -Ranolazine, Phase 2 -Placebo | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. Placebo: twice daily |
| OG002 | Phase 1 -Placebo, Phase 2 -Ranolazine | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. Placebo: twice daily |
| OG003 | Phase 1 -Placebo, Phase 2 -Placebo | 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. Placebo: twice daily |
|
|
| Secondary | Percentage Increase in Absolute Walking Distance Following Phase 2 | Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test | Missing data from one subject 24 week treadmill test in placebo/placebo group | Posted | Median | Inter-Quartile Range | percentage of baeline | 24 weeks |
|
|
|
| 0 |
| 3 |
| 1 |
| 3 |
| 0 |
| 3 |
| EG001 | Phase 1 -Ranolazine, Phase 2 -Placebo | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. Placebo: twice daily | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Phase 1 -Placebo, Phase 2 -Ranolazine | 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. Ranolazine: Ranolazine, 1000 mg, capsule, twice daily, by mouth. Placebo: twice daily | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Phase 1 -Placebo, Phase 2 -Placebo | 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. Placebo: twice daily | 0 | 8 | 0 | 8 | 0 | 8 |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |