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
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Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE |
Blood pressure at the end of each 4 week treatment period | |||
Change History | ||||
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:
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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 |
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Condition ICMJE | Hypertension | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
139 | |||
Original Enrollment ICMJE |
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:
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Sex/Gender ICMJE |
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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 | |||
Current Responsible Party | Hospices Civils de Lyon | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Hospices Civils de Lyon | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |