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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Indapamide (T2)
* Drug: Perindopril (T1)
* Drug: Placebo of Perindopril (P1)
* Drug: Placebo of Indapamide (P2)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2<br>T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 | Drug: Indapamide (T2)<br>* 1.5 mg/day during 4 weeks<br>Drug: Perindopril (T1)<br>* 4 mg/day during 1 week then 8 mg/day during 3 weeks<br>Drug: Placebo of Perindopril (P1)<br>* 1 pill/day during 1 week then 2 pills/day during 3 weeks<br>Drug: Placebo of Indapamide (P2)<br>* 1 pill/day during 4 weeks<br>|
| Experimental: Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1<br>T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 | Drug: Indapamide (T2)<br>* 1.5 mg/day during 4 weeks<br>Drug: Perindopril (T1)<br>* 4 mg/day during 1 week then 8 mg/day during 3 weeks<br>Drug: Placebo of Perindopril (P1)<br>* 1 pill/day during 1 week then 2 pills/day during 3 weeks<br>Drug: Placebo of Indapamide (P2)<br>* 1 pill/day during 4 weeks<br>|
| Experimental: Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2<br>T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 | Drug: Indapamide (T2)<br>* 1.5 mg/day during 4 weeks<br>Drug: Perindopril (T1)<br>* 4 mg/day during 1 week then 8 mg/day during 3 weeks<br>Drug: Placebo of Perindopril (P1)<br>* 1 pill/day during 1 week then 2 pills/day during 3 weeks<br>Drug: Placebo of Indapamide (P2)<br>* 1 pill/day during 4 weeks<br>|
| Experimental: Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2<br>T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 | Drug: Indapamide (T2)<br>* 1.5 mg/day during 4 weeks<br>Drug: Perindopril (T1)<br>* 4 mg/day during 1 week then 8 mg/day during 3 weeks<br>Drug: Placebo of Perindopril (P1)<br>* 1 pill/day during 1 week then 2 pills/day during 3 weeks<br>Drug: Placebo of Indapamide (P2)<br>* 1 pill/day during 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure at the end of each 4 week treatment period | Change from baseline and after each 4 week treatment period | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics