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Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00841880

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Ramipril + Felodipine Drug: Ramipril	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: 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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Felodipine Ramipril

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Seated SBP at office [ Time Frame: After 8-week treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	49
Study Start Date:	January 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841880

Locations

Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Fern Lim

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00841880 History of Changes
Other Study ID Numbers:	RAMFE_L_03420
Study First Received:	February 10, 2009
Last Updated:	August 26, 2010
Health Authority:	Taiwan: Department of Health

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Felodipine
Ramipril
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012