China Medical University Hospital (CMUH) Triapin Listing

Condition(s) targeted: Hypertension

Intervention: Ramipril + Felodipine (Drug); Ramipril (Drug); Ramipril (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Fern Lim, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
Public Registry GMA, Email: PublicRegistryGMA@sanofi-aventis.com

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Seated SBP at office

Secondary outcome:

Seated DBP at office

Seated SBP at office

Response rate

BP controlled rate

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Public Registry GMA, Email: PublicRegistryGMA@sanofi-aventis.com

Sanofi-Aventis Administrative Office, Taipei, Taiwan; Recruiting

Starting date: January 2009
Last updated: February 11, 2009