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

Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Indapamide (T2) (Drug); Perindopril (T1) (Drug); Placebo of Perindopril (P1) (Drug); Placebo of Indapamide (P2) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Francois GUEYFFIER, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Blood pressure at the end of each 4 week treatment period

Eligibility

Minimum age: 25 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Hôpital Louis Pradel, BRon 69677, France
Additional Information

Starting date: October 2004
Last updated: December 29, 2011

Page last updated: August 23, 2015

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