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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00128518
First received: August 9, 2005
Last updated: December 29, 2011
Last verified: December 2011
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Indapamide
Perindopril
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014