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Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities (STERILE)

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ClinicalTrials.gov Identifier: NCT00914316
Recruitment Status : Terminated
First Posted : June 4, 2009
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
William Beaumont Hospitals

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Peripheral Arterial Disease
Interventions: Drug: Ranolazine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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
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
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

Participant Flow for 2 periods

 Period 1:   Phase 1
    Phase 1-Ranolazine, Phase 2-Ranolazine   Phase 1 -Ranolazine, Phase 2 -Placebo   Phase 1 -Placebo, Phase 2 -Ranolazine   Phase 1 -Placebo, Phase 2 -Placebo
STARTED   7   6   8   8 
COMPLETED   2   4   3   6 
NOT COMPLETED   5   2   5   2 
Physician Decision                4                0                1                2 
Withdrawal by Subject                0                2                4                0 
Adverse Event                1                0                0                0 

Period 2:   Phase 2
    Phase 1-Ranolazine, Phase 2-Ranolazine   Phase 1 -Ranolazine, Phase 2 -Placebo   Phase 1 -Placebo, Phase 2 -Ranolazine   Phase 1 -Placebo, Phase 2 -Placebo
STARTED   2   4   3   6 
COMPLETED   1   4   2   6 
NOT COMPLETED   1   0   1   0 
Withdrawal by Subject                1                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Missing data for 4 participants in Ranolazine/Ranolazine group, and 2 participants in placebo/Ranolazine group.

Reporting Groups
  Description
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.
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
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
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
Total Total of all reporting groups

Baseline Measures
   Phase 1-Ranolazine, Phase 2-Ranolazine   Phase 1 -Ranolazine, Phase 2 -Placebo   Phase 1 -Placebo, Phase 2 -Ranolazine   Phase 1 -Placebo, Phase 2 -Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 3   6   6   8   23 
Age 
[Units: Participants]
Count of Participants 		         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1  33.3%      2  33.3%      1  16.7%      4  50.0%      8  34.8% 
>=65 years      2  66.7%      4  66.7%      5  83.3%      4  50.0%      15  65.2% 
Age 
[Units: Years]
Mean (Standard Deviation) 		 69.0  (3.6)   69.7  (6.9)   77.0  (10.5)   65.8  (14.9)   70.1  (11.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		         
Female      0   0.0%      2  33.3%      1  16.7%      0   0.0%      3  13.0% 
Male      3 100.0%      4  66.7%      5  83.3%      8 100.0%      20  87.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants 		         
United States   3   6   6   8   23 


  Outcome Measures

1.  Primary:   Percentage Increase in Absolute Walking Distance Following Phase 1   [ Time Frame: 12 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Percentage Increase in Absolute Walking Distance Following Phase 2   [ Time Frame: 24 weeks ]
  Show Outcome Measure 2


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to recruitment and retention difficulties, leading to small numbers of subjects. Missing data for several subjects.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Barbara Higgins, RN
Organization: William Beaumont Hospital
phone: 248 551-1535
e-mail: Barbara.Higgins@beaumont.org



Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00914316     History of Changes
Other Study ID Numbers: 2009-051
First Submitted: June 2, 2009
First Posted: June 4, 2009
Results First Submitted: April 3, 2017
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017