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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014