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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)
NCT00644332 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00644332 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00644332?
The interventions under investigation include: Ranolazine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00644332?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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