China Medical University Hospital (CMUH) Triapin Listing

A Prospective, Open Label, Randomized, Comparative Study of Ramipril 5mg Plus Felodipine 5mg Combined Regimen and Ramipril 10mg in Uncontrolled Hypertensive Patients

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Ramipril + Felodipine; Drug: Ramipril; Drug: Ramipril

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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; 10 mg 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Seated SBP at office	After 8-week treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Seated DBP at office	After 4 and 8-week treatment
Seated SBP at office	After 4-week treatment
Response rate	After 4 and 8-week treatment
BP controlled rate	After 4 and 8-week treatment

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): September 1, 2009
• Study Completion (ACTUAL): September 1, 2009

Study Registration Dates

• First Submitted: February 10, 2009
• First Submitted That Met QC Criteria: February 10, 2009
• First Posted (ESTIMATE): February 11, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 27, 2010
• Last Update Submitted That Met QC Criteria: August 26, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Protease Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin-Converting Enzyme Inhibitors; Felodipine; Ramipril
• Other Study ID Numbers: RAMFE_L_03420