Ramipril - Hypertension

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00325806
• Collaborator: (none)
• Enrollment: 1,008
• Duration (Months): 63

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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 1, 2000
• Actual Primary Completion Date: Aug 1, 2005
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• 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

Locations

No locations specified.

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00325806
• Other Study ID Numbers: HOE498_3E03
• First Posted: May 15, 2006
• Last Update Posted: Mar 8, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Hypertension; Ramipril

Study Results

No Results Posted as of Mar 8, 2013