IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs - Full Text View

Sponsor:	Hospices Civils de Lyon
Information provided by (Responsible Party):	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00128518

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Indapamide (T2) Drug: Perindopril (T1) Drug: Placebo of Perindopril (P1) Drug: Placebo of Indapamide (P2)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	IDEAL Study : Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Indapamide Perindopril Perindopril erbumine

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Blood pressure at the end of each 4 week treatment period [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change from baseline and after each 4 week treatment period

Enrollment:	139
Study Start Date:	October 2004
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2 T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2	Drug: Indapamide (T2) 1.5 mg/day during 4 weeks Drug: Perindopril (T1) 4 mg/day during 1 week then 8 mg/day during 3 weeks Drug: Placebo of Perindopril (P1) 1 pill/day during 1 week then 2 pills/day during 3 weeks Drug: Placebo of Indapamide (P2) 1 pill/day during 4 weeks
Experimental: Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1 T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2	Drug: Indapamide (T2) 1.5 mg/day during 4 weeks Drug: Perindopril (T1) 4 mg/day during 1 week then 8 mg/day during 3 weeks Drug: Placebo of Perindopril (P1) 1 pill/day during 1 week then 2 pills/day during 3 weeks Drug: Placebo of Indapamide (P2) 1 pill/day during 4 weeks
Experimental: Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2 T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2	Drug: Indapamide (T2) 1.5 mg/day during 4 weeks Drug: Perindopril (T1) 4 mg/day during 1 week then 8 mg/day during 3 weeks Drug: Placebo of Perindopril (P1) 1 pill/day during 1 week then 2 pills/day during 3 weeks Drug: Placebo of Indapamide (P2) 1 pill/day during 4 weeks
Experimental: Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2 T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2	Drug: Indapamide (T2) 1.5 mg/day during 4 weeks Drug: Perindopril (T1) 4 mg/day during 1 week then 8 mg/day during 3 weeks Drug: Placebo of Perindopril (P1) 1 pill/day during 1 week then 2 pills/day during 3 weeks Drug: Placebo of Indapamide (P2) 1 pill/day during 4 weeks

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128518

Locations

France
Hôpital Louis Pradel
BRon, France, 69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Francois GUEYFFIER, MD

Hospices Civils de Lyon

More Information

No publications provided

Responsible Party:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00128518 History of Changes
Other Study ID Numbers:	2003.340
Study First Received:	August 9, 2005
Last Updated:	December 29, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Indapamide
Perindopril
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012