China Medical University Hospital (CMUH) Triapin Listing

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Ramipril + Felodipine; Drug: Ramipril

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841880

RAMFE_L_03420

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

1

Experimental group

Description:

2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine

Treatment:

Drug: Ramipril

Drug: Ramipril

Drug: Ramipril + Felodipine

2

Active Comparator group

Description:

2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg

Treatment:

Drug: Ramipril

Drug: Ramipril