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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 September 18, 2014