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NCT01425359 · ClinicalTrials.gov registry record · Phase 4
Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina
A Phase 4 study of Coronary Artery Disease and Type 2 Diabetes Mellitus, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 949
- Enrollment target
- 20
- Study locations
NCT01425359: Completed Phase 4 study of Coronary Artery Disease and Type 2 Diabetes Mellitus, sponsored by Gilead Sciences.
NCT01425359 is a Phase 4 study of Coronary Artery Disease and Type 2 Diabetes Mellitus that has completed, run by Gilead Sciences. The registered enrollment target is 949 participants, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01425359, a Phase 4 study of Coronary Artery Disease and Type 2 Diabetes Mellitus, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 949 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (chest pain) attacks, compared to a placebo. Subjects will be asked to record their daily angina episodes in a diary at the end of each study day. Ranolazine is approved for the treatment of chronic angina, and is not approved for the treatment of T2DM.
Primary Outcome
Average weekly angina frequency was defined as the total number of angina episodes reported during the last 6 weeks of treatment divided by 6 weeks. For subjects who terminated with less than 6 weeks of treatment, frequency was calculated as the total number of angina episodes reported during the treatment period divided by the subject's actual duration of treatment.
Conditions Studied
Interventions
- DRUG Ranolazine
- DRUG Ranolazine placebo
Study Locations (20)
California
- Merced Heart Associates - Merced
- Spectrum Clinical Research Institute, Inc - Moreno Valley
- Sacramento Heart and Vascular Research Center - Sacramento
Florida
- South Florida Research Solutions, LLC - Hollywood
- Baptist Heart Specialist - Jacksonville
- Clinical Research of Central Florida - Winter Haven
Georgia
- Masters of Clinical Research, Inc. - Augusta
- Columbus Cardiology Associates - Columbus
Kentucky
- Central Cardiology Associates - Elizabethtown
- Research Integrity, LLC - Owensboro
Louisiana
- Alexandria Cardiology Clinic - Alexandria
- Clinical Trials Management, LLC - Mandeville
Tennessee
- Kore CV Research - Jackson
- Wellmont Cardiovascular Associates Heart Institute - Johnson City
Texas
- Med-Tech Research - Houston
- Humble Cardiology Associates - Humble
Arkansas
- Cardiology and Medicine Clinic - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 949 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-10 |
| Phase | Phase 4 |
What the finished NCT01425359 record still lists
NCT01425359 is an interventional study that assigns participants to a tested intervention. The registered 949 participants enrollment target is mid-sized for trials with a published cap, below the 1,283-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (26% lower).
The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Ranolazine is the first listed.
NCT01425359 names 20 study sites across 11 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01425359 about?
NCT01425359 is a clinical study titled "Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina". This study will evaluate the effect of ranolazine compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether ranolazine can reduce the frequency of angina (ches...
What is the current status of trial NCT01425359?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 949 participants. The study started on 2011-09. Estimated completion is 2012-10.
What conditions does trial NCT01425359 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Type 2 Diabetes Mellitus, Angina Pectoris.
What interventions are being tested in trial NCT01425359?
The interventions under investigation include: Ranolazine (DRUG), Ranolazine placebo (DRUG).
Who is sponsoring clinical trial NCT01425359?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01425359 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01425359's enrollment target sits among peer trials
949 52nd of 219 higher than 168 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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