IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs
- Conditions
- Hypertension
- Interventions
- Drug: Placebo of Perindopril (P1)Drug: Placebo of Indapamide (P2)
- Registration Number
- NCT00128518
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2 Perindopril (T1) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2 Indapamide (T2) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2 Perindopril (T1) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2 Indapamide (T2) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2 Perindopril (T1) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2 Placebo of Perindopril (P1) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2 Placebo of Indapamide (P2) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1 Indapamide (T2) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2 Indapamide (T2) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2 Placebo of Perindopril (P1) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2 Placebo of Indapamide (P2) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1 Perindopril (T1) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1 Placebo of Perindopril (P1) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1 Placebo of Indapamide (P2) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2 Placebo of Perindopril (P1) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2 Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2 Placebo of Indapamide (P2) T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
- Primary Outcome Measures
Name Time Method Blood pressure at the end of each 4 week treatment period 16 weeks Change from baseline and after each 4 week treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpital Louis Pradel
🇫🇷BRon, France