Text Size

China Medical University Hospital (CMUH) Triapin Listing

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00841880
First received: February 10, 2009
Last updated: August 26, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Hypertension
 Drug: Ramipril + Felodipine
Drug: Ramipril
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Seated SBP at office [ Time Frame: After 8-week treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seated DBP at office [ Time Frame: After 4 and 8-week treatment ] [ Designated as safety issue: No ]
  • Seated SBP at office [ Time Frame: After 4-week treatment ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: After 4 and 8-week treatment ] [ Designated as safety issue: No ]
  • BP controlled rate [ Time Frame: After 4 and 8-week treatment ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841880

Locations
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Fern Lim Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00841880     History of Changes
Other Study ID Numbers: RAMFE_L_03420
Study First Received: February 10, 2009
Last Updated: August 26, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Felodipine
Ramipril
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013