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History of Changes for Study: NCT00128518
IDEAL Study
Latest version (submitted December 29, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 9, 2005 None (earliest Version on record)
2 August 23, 2005 Contacts/Locations, Study Status and Study Identification
3 August 25, 2005 Eligibility, Arms and Interventions, Study Description, Study Status and Study Identification
4 August 31, 2005 Study Identification and Study Status
5 December 29, 2005 Eligibility, Study Status and Study Identification
6 March 10, 2006 Study Status and Contacts/Locations
7 April 26, 2007 Study Status
8 October 3, 2007 Study Status and Study Design
9 December 28, 2011 Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations, Study Design, Outcome Measures, Oversight and Sponsor/Collaborators
10 December 29, 2011 Outcome Measures and Study Status
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Study NCT00128518
Submitted Date:  August 9, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2003-340
Brief Title: IDEAL Study
Official Title: Identification of the Determinants of the Efficacy of Arterial Blood Pressure Lowering Drugs
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2004
Overall Status: Recruiting
Study Start: October 2004
Primary Completion:
Study Completion:
First Submitted: August 9, 2005
First Submitted that
Met QC Criteria:
August 9, 2005
First Posted: August 10, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 9, 2005
Last Update Posted: August 10, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hospices Civils de Lyon
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

• The principal scientific objective of the trial is to identify the factors that are associated differential blood pressure response between drugs. This may allow to produce new hypotheses on pathophysiology of hypertension and on the mechanisms of action of drugs

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
  • ECG parameters of left ventricular hypertrophy
  • Biological parameters as the activity level of renin angiotensin aldosterone system
  • Genetic polymorphisms
Detailed Description:
Open or close this module Conditions
Conditions: Hypertension
Keywords: Hypertension - Drugs - Blood pressure response - Responders - pharmacogenetics
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Crossover Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 400
Open or close this module Arms and Interventions
Intervention Details:
Drug: Indapamide
Drug: perindopril
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Blood pressure at the end of each 4 week treatment period
Open or close this module Eligibility
Minimum Age: 25 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Participants have to be 25 to 60 years of age, from both genders, with systolic blood pressure of 140mmHg or above, diastolic blood pressure of 90 mmHg or above.

Their cardiovascular risk must not be high, to allow two periods of 4 weeks of placebo without ethical concern.

Exclusion Criteria:

-

Open or close this module Contacts/Locations
Central Contact Person: François GUEYFFIER, MD
Telephone: 33 472 119 057
Email: francois.gueyffier@chu-lyon.fr
Study Officials: Francois GUEYFFIER, MD
Principal Investigator
Hospices Civils de Lyon
Locations: France
François Gueyffier
[Recruiting]
Lyon-BRon, France, 69677
Contact:Contact: François GUEYFFIER, MD 33 472 119 057 francois.gueyffier@chu-lyon.fr
Contact:Principal Investigator: François GUEYFFIER, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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