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

NCT ID: NCT00128518

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2

T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2

Group Type EXPERIMENTAL

Indapamide (T2)

Intervention Type DRUG

1.5 mg/day during 4 weeks

Perindopril (T1)

Intervention Type DRUG

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

Placebo of Perindopril (P1)

Intervention Type DRUG

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

Placebo of Indapamide (P2)

Intervention Type DRUG

1 pill/day during 4 weeks

Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1

T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2

Group Type EXPERIMENTAL

Indapamide (T2)

Intervention Type DRUG

1.5 mg/day during 4 weeks

Perindopril (T1)

Intervention Type DRUG

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

Placebo of Perindopril (P1)

Intervention Type DRUG

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

Placebo of Indapamide (P2)

Intervention Type DRUG

1 pill/day during 4 weeks

Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2

T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2

Group Type EXPERIMENTAL

Indapamide (T2)

Intervention Type DRUG

1.5 mg/day during 4 weeks

Perindopril (T1)

Intervention Type DRUG

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

Placebo of Perindopril (P1)

Intervention Type DRUG

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

Placebo of Indapamide (P2)

Intervention Type DRUG

1 pill/day during 4 weeks

Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2

T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2

Group Type EXPERIMENTAL

Indapamide (T2)

Intervention Type DRUG

1.5 mg/day during 4 weeks

Perindopril (T1)

Intervention Type DRUG

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

Placebo of Perindopril (P1)

Intervention Type DRUG

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

Placebo of Indapamide (P2)

Intervention Type DRUG

1 pill/day during 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Indapamide (T2)

1.5 mg/day during 4 weeks

Intervention Type DRUG

Perindopril (T1)

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

Intervention Type DRUG

Placebo of Perindopril (P1)

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

Intervention Type DRUG

Placebo of Indapamide (P2)

1 pill/day during 4 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francois GUEYFFIER, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Louis Pradel

Bron, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Gueyffier F, Subtil F, Bejan-Angoulvant T, Zerbib Y, Baguet JP, Boivin JM, Mercier A, Leftheriotis G, Gagnol JP, Fauvel JP, Giraud C, Bricca G, Maucort-Boulch D, Erpeldinger S; IDEAL Trial Group. Can we identify response markers to antihypertensive drugs? First results from the IDEAL Trial. J Hum Hypertens. 2015 Jan;29(1):22-7. doi: 10.1038/jhh.2014.29. Epub 2014 Apr 17.

Reference Type RESULT
PMID: 24739801 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2003.340

Identifier Type: -

Identifier Source: org_study_id