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Ramipril - Hypertension

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ClinicalTrials.gov Identifier: NCT00325806
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : March 8, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

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 or disease Intervention/treatment Phase
Hypertension Drug: Ramipril Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2000
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325806


Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Publications of Results:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00325806     History of Changes
Other Study ID Numbers: HOE498_3E03
First Posted: May 15, 2006    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

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