NCT00128518

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

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

October 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

5.9 years

First QC Date

August 9, 2005

Last Update Submit

December 13, 2025

Conditions

Hypertension

Keywords

Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics

Outcome Measures

Primary Outcomes (1)

  • Blood pressure at the end of each 4 week treatment period

    Change from baseline and after each 4 week treatment period

    16 weeks

Study Arms (4)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

Indapamide (T2)DRUG

1.5 mg/day during 4 weeks

Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2
Perindopril (T1)DRUG

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

Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2
Placebo of Perindopril (P1)DRUG

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

Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2
Placebo of Indapamide (P2)DRUG

1 pill/day during 4 weeks

Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Louis Pradel

Bron, 69677, France

Location

Related Publications (1)

  • 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.

    PMID: 24739801RESULT

MeSH Terms

Conditions

Hypertension

Interventions

IndapamidePerindoprilP-2

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Francois GUEYFFIER, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 10, 2005

Study Start

October 1, 2004

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

FR(1)