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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00128518
Enrollment
139
Registered
2005-08-10
Start date
2004-10-31
Completion date
2010-09-30
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics

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.

Interventions

DRUGIndapamide (T2)

1.5 mg/day during 4 weeks

DRUGPerindopril (T1)

4 mg/day during 1 week then 8 mg/day during 3 weeks

DRUGPlacebo of Perindopril (P1)

1 pill/day during 1 week then 2 pills/day during 3 weeks

DRUGPlacebo of Indapamide (P2)

1 pill/day during 4 weeks

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure at the end of each 4 week treatment period16 weeksChange from baseline and after each 4 week treatment period

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026