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

• ClinicalTrials.gov Identifier: NCT00128518
• Recruitment Status: Completed
• First Posted: August 10, 2005
• Last Update Posted: January 2, 2012
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Tracking Information

• First Submitted Date: August 9, 2005
• First Posted Date: August 10, 2005
• Last Update Posted Date: January 2, 2012
• Study Start Date: October 2004
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 29, 2011)

Blood pressure at the end of each 4 week treatment period [ Time Frame: 16 weeks ]

Change from baseline and after each 4 week treatment period

• Original Primary Outcome Measures (submitted: August 9, 2005): Blood pressure at the end of each 4 week treatment period
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• 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

Study Arms

• Experimental: Group A : T1+P2 ● P1+P2 ● T2+P1 ● P1+P2
  T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
  Interventions:

  • Drug: Indapamide (T2)
  • Drug: Perindopril (T1)
  • Drug: Placebo of Perindopril (P1)
  • Drug: Placebo of Indapamide (P2)
• Experimental: Group B : P1+P2 ● T1+P2 ● P1+P2 ● T2+P1
  T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
  Interventions:

  • Drug: Indapamide (T2)
  • Drug: Perindopril (T1)
  • Drug: Placebo of Perindopril (P1)
  • Drug: Placebo of Indapamide (P2)
• Experimental: Group C : T2+P1 ● P1+P2 ● T1+P2 ● P1+P2
  T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
  Interventions:

  • Drug: Indapamide (T2)
  • Drug: Perindopril (T1)
  • Drug: Placebo of Perindopril (P1)
  • Drug: Placebo of Indapamide (P2)
• Experimental: Group D : P1+P2 ● T2+P1 ● P1+P2 ● T1+P2
  T1 = perindopril T2 = Indapamide P1 = Placebo of T1 P2 = Placebo of T2
  Interventions:

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

• Publications *: Gueyffier F, Subtil F, Bejan-Angoulvant T, Zerbib Y, Baguet JP, Boivin JM, Mercier A, Leftheriotis G, Gagnol JP, Fauvel JP, Giraud C, Bricca G, Maucort-Boulch D, Erpeldinger S; IDEAL Trial Group. Can we identify response markers to antihypertensive drugs? First results from the IDEAL Trial. J Hum Hypertens. 2015 Jan;29(1):22-7. doi: 10.1038/jhh.2014.29. Epub 2014 Apr 17.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 28, 2011): 139
• Original Enrollment (submitted: August 9, 2005): 400
• Actual Study Completion Date: September 2010
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00128518
• Other Study ID Numbers: 2003.340
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hospices Civils de Lyon
• Original Responsible Party: Not Provided
• Current Study Sponsor: Hospices Civils de Lyon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Francois GUEYFFIER, MD; Hospices Civils de Lyon

• PRS Account: Hospices Civils de Lyon
• Verification Date: December 2011