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Ramipril - Hypertension

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: April 11, 2006
Last updated: March 7, 2013
Last verified: March 2013

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
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)

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00325806

Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi 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:
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents processed this record on October 26, 2016