Ramipril - Hypertension

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: NCT00325806
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-15
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1008

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean systolic and diastolic 24-hour blood pressure in ABPM

Secondary Outcome Measures

Name	Time	Method
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.