IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs - Tabular View

Tracking Information

First Received Date ^ICMJE

August 9, 2005

Last Updated Date

October 3, 2007

Start Date ^ICMJE

October 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Blood pressure at the end of each 4 week treatment period

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00128518 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs

Official Title ^ICMJE

IDEAL Study : Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs

Brief Summary

The principal scientific objective of the trial is to identify the factors that are associated with differential blood pressure responses between drugs. This may allow investigators to produce new hypotheses on the pathophysiology of hypertension and on the mechanisms of drug action.

These factors can be of different types:

Environmental factors (sodium or alcohol intake);
Morphological (height, weight, body mass index, body surface area);
Initial blood pressure;
Electrocardiogram (ECG) parameters of left ventricular hypertrophy;
Biological parameters as the activity level of the renin angiotensin aldosterone system;
Genetic polymorphisms.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Indapamide
Drug: Perindopril

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Participants have to be 25 to 60 years of age
Both genders
Systolic blood pressure of 140 mmHg or above; diastolic blood pressure of 90 mmHg or above.
Cardiovascular risk must not be high, to allow for two periods of 4 weeks of placebo without ethical concern.

Gender

Both

Ages

25 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: François GUEYFFIER, MD

33 472 119 057

francois.gueyffier@chu-lyon.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00128518

Responsible Party

Study ID Numbers ^ICMJE

2003.340

Study Sponsor ^ICMJE

Hospices Civils de Lyon

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Francois GUEYFFIER, MD

Hospices Civils de Lyon

Information Provided By

Hospices Civils de Lyon

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP