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

Civil Hospices of Lyon

Status and phase: Completed; Phase 4

Conditions: Hypertension

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00128518

2003.340

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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139 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Placebo of Perindopril (P1)

Drug: Perindopril (T1)

Drug: Placebo of Indapamide (P2)

Drug: Indapamide (T2)

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

Experimental group

Description:

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

Treatment:

Drug: Placebo of Perindopril (P1)

Drug: Perindopril (T1)

Drug: Placebo of Indapamide (P2)

Drug: Indapamide (T2)

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

Experimental group

Description:

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

Treatment:

Drug: Placebo of Perindopril (P1)

Drug: Perindopril (T1)

Drug: Placebo of Indapamide (P2)

Drug: Indapamide (T2)

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

Experimental group

Description:

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

Treatment:

Drug: Placebo of Perindopril (P1)

Drug: Perindopril (T1)

Drug: Placebo of Indapamide (P2)

Drug: Indapamide (T2)