Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
NCT ID: NCT00310778
Last Updated: 2008-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
64 participants
INTERVENTIONAL
2006-03-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
treatment
high sodium diet
high sodium diet
low sodium diet
low sodium diet
ramipril 10 mg
ramipril 10 mg
valsartan 160 mg
valsartan 160 mg
candesartan 8 mg
candesartan 8 mg
atenolol 50 mg
atenolol 50 mg
Interventions
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high sodium diet
high sodium diet
low sodium diet
low sodium diet
ramipril 10 mg
ramipril 10 mg
valsartan 160 mg
valsartan 160 mg
candesartan 8 mg
candesartan 8 mg
atenolol 50 mg
atenolol 50 mg
Eligibility Criteria
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Inclusion Criteria
* Aged between 18 and 35 years after a complete clinical examination
* Safety laboratory measurements
* Having given written informed consent.
Exclusion Criteria
* known disease
* diabetes mellitus
* known hypersensitivity
* contraindication to ACE inhibitors
* history of cardiac or pulmonary disease or asthma conditions which do not permit medical follow-up and compliance with the study protocol.
18 Years
35 Years
MALE
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department Clinical Research of Developpement
Principal Investigators
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Michel Azizi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou
Paris, , France
Countries
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References
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Azizi M, Menard J, Bissery A, Guyenne TT, Bura-Riviere A, Vaidyanathan S, Camisasca RP. Pharmacologic demonstration of the synergistic effects of a combination of the renin inhibitor aliskiren and the AT1 receptor antagonist valsartan on the angiotensin II-renin feedback interruption. J Am Soc Nephrol. 2004 Dec;15(12):3126-33. doi: 10.1097/01.ASN.0000146686.35541.29.
Other Identifiers
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P051201
Identifier Type: -
Identifier Source: org_study_id