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Ramipril - Hypertension
This study has been completed.

First Received on April 11, 2006.   Last Updated on September 11, 2007   History of Changes
Sponsor: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00325806
  Purpose

Primary objective:

Mean values of systolic and diastolic office blood pressure

Secondary objectives:

Total mortality, occurrence of cardio- and cerebrovascular events, change of mean blood pressure (ABPM : Ambulatory Blood Pressure Monitoring) during the observation


Condition Intervention Phase
Hypertension
 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: Prevention of Hypertension in Patients With High-Normal Blood Pressure With the ACE-Inhibitor Ramipril - a Randomised Prevention Trial of the Germany Hypertension League. (ACE : Angiotensin Converting Enzyme)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Ramipril
U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Mean systolic and diastolic 24-hour blood pressure in ABPM

Secondary Outcome Measures:
  • Overall mortality and total number of cardiovascular and cerebro-vascular events
  • Changes in mean blood pressure readings over time
  • Reasons for admissions to hospital/-stays
  • Occurrence of pathological fasting glucose levels in serum/pathological HbA1c levels.

Estimated Enrollment: 1010
Study Start Date: December 2000
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • no previous antihypertensive therapy
  • high-normal blood pressure according to the JNC-VI definition (systolic 130 - 139 and/or diastolic 85 - 89 mmHg)

Exclusion Criteria:

  • antihypertensive therapy
  • blood pressure greater 140/90 mmHg or ABPM greater 135/85 mmHg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325806

Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Katrin Roscher Sanofi-Aventis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00325806     History of Changes
Other Study ID Numbers: HOE498_3E03
Study First Received: April 11, 2006
Last Updated: September 11, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012



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