Ramipril - Hypertension
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Ramipril (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s): Katrin Roscher, Study Director, Affiliation: Sanofi-Aventis
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
Clinical Details
Official title: Prevention of Hypertension in Patients With High-Normal Blood Pressure With the ACE-Inhibitor Ramipril - a Randomised Prevention Trial of the Germany Hypertension League. (ACE : Angiotensin Converting Enzyme)
Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Mean systolic and diastolic 24-hour blood pressure in ABPM
Secondary outcome: Overall mortality and total number of cardiovascular and cerebro-vascular eventsChanges in mean blood pressure readings over time Reasons for admissions to hospital/-stays Occurrence of pathological fasting glucose levels in serum/pathological HbA1c levels.
Eligibility
Minimum age: 50 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Information on study results
Starting date: December 2000
Last updated: September 11, 2007
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