Status:
COMPLETED
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)
Lead Sponsor:
Gilead Sciences
Conditions:
Chronic Angina
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 t...
Eligibility Criteria
Inclusion
- At least 3 months of documented history of stable angina or angina equivalents that is relieved by rest and/or sublingual NTG
- Taking antianginal therapy with beta-blockers, and/or dihydropyridine calcium antagonists, and/or long-acting nitrates for at least 4 weeks
- Mean angina frequency of ≥ 2 attacks per week
- Documented clinical evidence of ischemia
Exclusion
- Clinically significant hepatic impairment
- Uncontrolled clinically significant cardiac arrhythmias or a history of ventricular fibrillation, torsades de points, or other life-threatening ventricular arrhythmias not associated with acute coronary syndrome
- Treatment with strong cytochrome P450 inhibitors including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, or saquinavir
- Prior treatment with ranolazine
- End-stage renal disease requiring dialysis
- Myocardial infarction or unstable angina
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00644332
Start Date
November 1 2007
End Date
January 1 2011
Last Update
July 2 2012
Active Locations (29)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0007
2
Cardiovascular Consultants, Ltd.
Phoenix, Arizona, United States, 85032
3
Cardiology Consultants of Orange County
Anaheim, California, United States, 92801
4
Access Clinical Trials/Cardiovascular Research Institute (ACT/CVRI)
Beverly Hills, California, United States, 90210