Clinical trial NCT00841880: China Medical University Hospital (CMUH) Triapin Listing
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Seated SBP at office
timeFrame: After 8-week treatment
Secondary outcomes:
measure: Seated DBP at office
timeFrame: After 4 and 8-week treatment
measure: Seated SBP at office
timeFrame: After 4-week treatment
measure: Response rate
timeFrame: After 4 and 8-week treatment
measure: BP controlled rate
timeFrame: After 4 and 8-week treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Fern Lim
role: STUDY_DIRECTOR
References: