Full Text View
Tabular View
No Study Results Posted
Related Studies
Ramipril - Hypertension
This study has been completed.
First Received: April 11, 2006   Last Updated: September 11, 2007   History of Changes
Sponsored by: 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

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Ramipril
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

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

Additional Information:
Information on study results  This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
 Ramipril
Protease Inhibitors
Hypertension

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

ClinicalTrials.gov processed this record on May 07, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services