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Ramipril - Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00325806
First received: April 11, 2006
Last updated: March 7, 2013
Last verified: March 2013
History of Changes
  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 4

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 Angiotensin-Converting-Enzyme-Inhibitor Ramipril - a Randomised Prevention Trial of the German Hypertension League.

Resource links provided by NLM:

Drug Information available for: Ramipril
U.S. FDA Resources

Further study details as provided by Sanofi:

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.

Enrollment: 1008
Study Start Date: May 2000
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  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
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00325806     History of Changes
Other Study ID Numbers: HOE498_3E03
Study First Received: April 11, 2006
Last Updated: March 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on June 18, 2013