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China Medical University Hospital (CMUH) Triapin Listing

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ClinicalTrials.gov Identifier: NCT00841880
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:

The objective of this study is to compare the reduction in office seated systolic blood pressure (BP) following a 8 weeks regimen of ramipril 5mg plus felodipine 5mg versus ramipril 10mg.

To compare the response rate (defined as office systolic blood pressure (SBP) / Diastolic blood pressure (DBP) reduce more than 10mmHg from baseline), and BP controlled rate (defined as SBP<140mmHg and/or DBP<90mmHg) and as SBP < 130 mmHg and /or DBP < 80 mmHg in diabetes,chronic kidney disease, known Coronary Arterial Disease (CAD) or CAD equivalent, or 10-year Framingham risk score > 10%.

To ascertain the safety and tolerability of ramipril/felodipine versus ramipril in Taiwanese population.

To compare compliance with fixed dose combination of ramipril/felodipine versus ramipril treatment.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Ramipril + Felodipine Drug: Ramipril Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients
Study Start Date : January 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine
 Drug: Ramipril + Felodipine
Ramipril 5mg + Felodipine 5mg once a day
Drug: Ramipril
5mg once a day
Active Comparator: 2
2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg
 Drug: Ramipril
10 mg once a day
Drug: Ramipril
5mg once a day


Outcome Measures
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Primary Outcome Measures :
  1. Seated SBP at office [ Time Frame: After 8-week treatment ]

Secondary Outcome Measures :
  1. Seated DBP at office [ Time Frame: After 4 and 8-week treatment ]
  2. Seated SBP at office [ Time Frame: After 4-week treatment ]
  3. Response rate [ Time Frame: After 4 and 8-week treatment ]
  4. BP controlled rate [ Time Frame: After 4 and 8-week treatment ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Uncontrolled essential hypertension defined by office SBP/DBP > 140/90 or > 130/80 mmHg for compelling indications (diabetes mellitus, chronic kidney disease, known CAD or CAD equivalent or 10-year Framingham risk score > 10%)
  • Previously untreated, or previously treated with a single antihypertensive therapy at usual dose during the last 4 weeks

Exclusion criteria:

  • Female who are pregnant or breast feeding
  • Office DBP> 110mmHg or office SBP >180mmHg
  • Hypersensitivity to ramipril, felodipine or to any of the excipients
  • Bilateral stenosis of the renal arteries, or unilateral stenosis in the single kidney
  • History of intolerance to any ACE inhibitor
  • History of significant renal diseases including: serum creatinine >3.0 mg/dl, or creatinine clearance <30 ml/min
  • History of hereditary and/or idiopathic angioedema; or angioedema associated with previous ACEI
  • Significant cardiovascular diseases, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication
  • Hepatic disease as indicated by any of the following: Serum Glutamooxaloacetate Transferase (SGOT) or Serum Glutamopyruvate Transferase (SGPT)>3 x upper limit of normal, or serum bilirubin > 2 x upper limit of normal
  • Any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objective.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841880


Locations
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Fern Lim Sanofi
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00841880     History of Changes
Other Study ID Numbers: RAMFE_L_03420
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Ramipril
Felodipine
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Antihypertensive Agents
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents