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

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

Tracking Information
First Submitted Date  ICMJE August 9, 2005
First Posted Date  ICMJE August 10, 2005
Last Update Posted Date January 2, 2012
Study Start Date  ICMJE October 2004
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: August 9, 2005)
Blood pressure at the end of each 4 week treatment period
Change History Complete list of historical versions of study NCT00128518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IDEAL Study: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2011)
139
Original Enrollment  ICMJE
 (submitted: August 9, 2005)
400
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00128518
Other Study ID Numbers  ICMJE 2003.340
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francois GUEYFFIER, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP