Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina (RAFEHELP)
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ClinicalTrials.gov Identifier: NCT00507845 |
Recruitment Status
:
Completed
First Posted
: July 27, 2007
Last Update Posted
: April 17, 2009
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Sponsor:
Sanofi
Information provided by:
Sanofi
Tracking Information | ||||
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First Submitted Date ICMJE | July 26, 2007 | |||
First Posted Date ICMJE | July 27, 2007 | |||
Last Update Posted Date | April 17, 2009 | |||
Study Start Date ICMJE | June 2007 | |||
Actual Primary Completion Date | April 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Mean changes in Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00507845 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina | |||
Official Title ICMJE | Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina | |||
Brief Summary | Primary:
Secondary:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | |||
Intervention ICMJE | Drug: Ramipril-Felodipine
Ramipril + felodipine 2.5/2.5mg per tablet. One tablet to be taken Od for 8 weeks (this dose could be increased at week 2 to 4 to 5 mg daily because of uncontrolled hypertension).
Other Name: Triacor |
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Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
271 | |||
Original Estimated Enrollment ICMJE |
369 | |||
Study Completion Date | Not Provided | |||
Actual Primary Completion Date | April 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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Sex/Gender |
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Ages | 21 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00507845 | |||
Other Study ID Numbers ICMJE | RAMIP_L_01961 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Medical Affairs Study Director, sanofi-aventis | |||
Study Sponsor ICMJE | Sanofi | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sanofi | |||
Verification Date | April 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |