NCT00325806

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,008

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started May 2000

Longer than P75 for phase_4 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

5.3 years

First QC Date

April 11, 2006

Last Update Submit

March 7, 2013

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean systolic and diastolic 24-hour blood pressure in ABPM

Secondary Outcomes (4)

  • 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.

Interventions

RamiprilDRUG

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • no previous antihypertensive therapy
  • high-normal blood pressure according to the JNC-VI definition (systolic 130 - 139 and/or diastolic 85 - 89 mmHg)

You may not qualify if:

  • antihypertensive therapy
  • blood pressure greater 140/90 mmHg or ABPM greater 135/85 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Luders S, Schrader J, Berger J, Unger T, Zidek W, Bohm M, Middeke M, Motz W, Lubcke C, Gansz A, Brokamp L, Schmieder RE, Trenkwalder P, Haller H, Dominiak P; PHARAO Study Group. The PHARAO study: prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure: a prospective, randomized, controlled prevention trial of the German Hypertension League. J Hypertens. 2008 Jul;26(7):1487-96. doi: 10.1097/HJH.0b013e3282ff8864.

    PMID: 18551027RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2006

First Posted

May 15, 2006

Study Start

May 1, 2000

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

March 8, 2013

Record last verified: 2013-03