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

February 10, 2009
August 26, 2010
January 2009
September 2009   (final data collection date for primary outcome measure)
Seated SBP at office [ Time Frame: After 8-week treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00841880 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: Ramipril + Felodipine
    Ramipril 5mg + Felodipine 5mg once a day
  • Drug: Ramipril
    10 mg once a day
  • Drug: Ramipril
    5mg once a day
  • Experimental: 1
    2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril + Felodipine
    Interventions:
    • Drug: Ramipril + Felodipine
    • Drug: Ramipril
  • Active Comparator: 2
    2 weeks run-in of Ramipril 5 mg followed by 8 weeks of Ramipril 10 mg
    Interventions:
    • Drug: Ramipril
    • Drug: Ramipril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
September 2009
September 2009   (final data collection date for primary outcome measure)

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.

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00841880
RAMFE_L_03420
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Fern Lim Sanofi
Sanofi
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP