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NCT00644332 · ClinicalTrials.gov registry record · Phase 4
An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)
A Phase 4 study of Chronic Angina, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 172
- Enrollment target
- 20
- Study locations
NCT00644332 is a Phase 4 study of Chronic Angina that has completed, run by Gilead Sciences. The registered enrollment target is 172 participants. The trial reports 20 study locations across 10 states.
The verdict
NCT00644332, a Phase 4 study of Chronic Angina, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 172 participants
- Enrollment target
- 20
- Study locations
Study Summary
According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete or near complete elimination of anginal chest pain and a return to normal activities and functional capacity. However, evaluating angina and responses to antianginal therapy is often not straightforward. This is particularly true of female patients with angina. Because angina and response to antianginal therapy may differ in men and women, an instrument designed specifically to address symptomatology in women with angina could enhance our understanding and characterization of angina and responses to therapy in this population. The current study will evaluate the validity, reliability, and responsiveness of the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ).
Conditions Studied
Interventions
- DRUG Ranolazine
Study Locations (20)
California
- Cardiology Consultants of Orange County - Anaheim
- Access Clinical Trials/Cardiovascular Research Institute (ACT/CVRI) - Beverly Hills
- Escondido Cardiology Associates - Escondido
- Cedars-Sinai Medical Center - Los Angeles
- Mission Internal Medical Group - Mission Viejo
Florida
- Guerra Cardiology - Coral Gables
- Jacksonville Center for Clinical Research - Jacksonville
- St. Luke Cardiology Associates - Jacksonville
- Jacksonville Heart Center, PA - Jacksonville
- Jacksonville Heart Center, PA - Jacksonville
Illinois
- North Shore Cardiology - Bannockburn
- Gateway Cardiology, P.C. - Jerseyville
Kentucky
- Ashland Hospital Corporation d/b/a King's Daughters Medical Center - Ashland
- University of Louisville, Division of Cardiovascular Medicine - Louisville
Alabama
- The University of Alabama at Birmingham - Birmingham
Arizona
- Cardiovascular Consultants, Ltd. - Phoenix
Colorado
- South Denver Cardiology Associates, PC - Littleton
Georgia
- Emory University & Grady Health System - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00644332
The ClinicalTrials.gov registry entry for NCT00644332 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Angina appearing as the primary indexed condition, and to 1 intervention - of which Ranolazine is the first listed.
NCT00644332 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT00644332 about?
NCT00644332 is a clinical study titled "An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)". According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 ...
What is the current status of trial NCT00644332?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 172 participants. The study started on 2007-11. Estimated completion is 2011-01.
What conditions does trial NCT00644332 study?
This clinical trial studies the following conditions: Chronic Angina.
What interventions are being tested in trial NCT00644332?
The interventions under investigation include: Ranolazine (DRUG).
Who is sponsoring clinical trial NCT00644332?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00644332 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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