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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00644332
First received: March 24, 2008
Last updated: May 29, 2012
Last verified: May 2012
History of Changes
Results First Received: May 29, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Chronic Angina
Intervention: Drug: Ranolazine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled at a total of 30 study sites in the US. The first patient was screened on 07 November 2007, and the last patient was screened on 06 December 2010. The last patient observation was on 20 January 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the 2-week qualifying phase, patients continued antianginal medications without changing dose or frequency and completed questionnaires to document angina symptoms, treatment and status. Patients who had average angina frequency of ≥ 2 attacks/week during this phase and met all enrollment criteria were enrolled in the open-label treatment phase.

Reporting Groups
  Description
Ranolazine In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.

Participant Flow:   Overall Study
    Ranolazine  
STARTED     171 [1]
COMPLETED     150  
NOT COMPLETED     21  
Adverse Event                 11  
Withdrawal by Subject                 6  
Completion Status Unknown                 2  
Did Not Meet Eligibility Requirements                 1  
Could Not Attend Scheduled Visits                 1  
[1] 172 patients were enrolled; one withdrew consent prior to starting treatment



  Baseline Characteristics
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Reporting Groups
  Description
Ranolazine In the open-label treatment phase (approximately 4 weeks’ duration), patients were given open-label ranolazine extended-release (ER) tablets 500 mg twice daily and continued to take their baseline antianginal medications. Patients completed self-administered questionnaires to document angina symptoms, response to antianginal treatment, and functional status. They also completed daily diaries to document the occurrence of angina episodes and NTG consumption.

Baseline Measures
    Ranolazine  
Number of Participants  
[units: participants]
 		  171  
Age  
[units: years]
Mean ± Standard Deviation 		  64.6  ± 12.0  
Gender  
[units: participants]
 		 
Female     171  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 		 
Asian     3  
Black     20  
Caucasian     143  
Hispanic     5  
Region of Enrollment  
[units: participants]
 		 
United States     171  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation 		  29.5  ± 6.3  
Weight  
[units: kg]
Mean ± Standard Deviation 		  76.7  ± 17.6  



  Outcome Measures
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1.  Primary:   Evaluate the Validity of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and Nitroglycerin (NTG) Consumption Before and Following Treatment With Ranolazine Assessed as Coefficient of Determination (R^2)   [ Time Frame: Baseline to Week 4 ]
  Show Outcome Measure 1

2.  Primary:   Evaluate the Reliability of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed as Cronbach's Alpha Value   [ Time Frame: Baseline to Week 4 ]
  Show Outcome Measure 2

3.  Primary:   Evaluate the Responsiveness of the WISQ in Women With Chronic Angina Based on Changes in Patient-reported Angina Frequency and NTG Consumption Before and Following Treatment With Ranolazine Assessed by Regression Analysis   [ Time Frame: Baseline to Week 4 ]
  Show Outcome Measure 3

4.  Secondary:   Determine Whether the WISQ is Noninferior to the Seattle Angina Questionnaire (SAQ) With Regard to Angina Frequency Items Based on Changes From Baseline (BL) in the Angina Frequency Items of the WISQ With the SAQ Following Ranolazine Treatment   [ Time Frame: Baseline to 4 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Compare Changes From Baseline (BL) in the Physical Limitation Items of the WISQ With the SAQ Following Ranolazine Treatment   [ Time Frame: Baseline to 4 Weeks ]
  Show Outcome Measure 5

6.  Secondary:   Compare Changes From Baseline (BL) in Other Like Items of the WISQ With the SAQ Following Ranolazine Treatment   [ Time Frame: Baseline to 4 Weeks ]
  Show Outcome Measure 6

7.  Secondary:   Determine the Effect of Ranolazine on Angina Frequency as Measured by Patient-reported Diaries   [ Time Frame: Baseline to Week 4 ]
  Show Outcome Measure 7

8.  Secondary:   Determine the Effect of Ranolazine on Nitroglycerin Consumption as Measured by Patient-reported Diaries   [ Time Frame: Baseline to Week 4 ]
  Show Outcome Measure 8

9.  Secondary:   Determine Changes From Baseline in the Duke Activity Status Index (DASI) Following Ranolazine Treatment   [ Time Frame: Baseline to Week 4 ]
  Show Outcome Measure 9

10.  Secondary:   Evaluate the Degree of Correlation Between Changes From Baseline in Items of the WISQ and SAQ With Changes From Baseline in Angina Frequency and NTG Diary Data and the DASI   [ Time Frame: Baseline to Week 4 ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
The study was terminated early at 86% of targeted enrollment (172 of approximately 200 subjects).  


Results Point of Contact:  
Name/Title: Emmanuelle Bellemin, Senior Manager, Regulatory Affairs
Organization: Gilead Sciences
e-mail: emmanuelle.bellemin@gilead.com


No publications provided


Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00644332     History of Changes
Other Study ID Numbers: CVT 3041
Study First Received: March 24, 2008
Results First Received: May 29, 2012
Last Updated: May 29, 2012
Health Authority: United States: Institutional Review Board