Effects of Sodium Intake on(PK)/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: high sodium diet (Drug); low sodium diet (Drug); ramipril 10 mg (Drug); valsartan 160 mg (Drug); candesartan 8 mg (Drug); atenolol 50 mg (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Michel Azizi, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Michel Azizi, MD, PhD, Phone: +33 (0) -1 56 09 29 12, Email: michel.azizi@egp.aphp.fr
Summary
The impact of sodium intake on plasma drug concentrations has previously been reported in the
literature for verapamil and quinidine but, to the investigators' knowledge, never with
renin-angiotensin system (RAS) blockers such as AT1R antagonists and angiotensin converting
enzyme (ACE) inhibitors.
Clinical Details
Official title: Effects of Sodium Intake on Pharmacokinetic/Pharmacodynamic Relationship of a Single Dose of a Renin Angiotensin System-Blocker, or a Beta-Blocker in Normotensive Sodium-Depleted or Replated Volunteers in a Cross-Over Study
Study design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion
Detailed description:
The impact of sodium intake on plasma drug concentrations concentrations obtained after a
single oral dose of RAS blocking drugs (ramipril 10 mg, valsartan 160 mg, candesartan 8 mg)
or a -blocker as control (atenolol 50 mg) will be compared in healthy normotensive men
randomly assigned to a 6-day replated-sodium diet or a sodium depletion.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 64 (16 per treatment goup) non-smoking healthy male volunteers
- Aged between 18 and 35 years after a complete clinical examination
- Safety laboratory measurements
- Having given written informed consent.
Exclusion Criteria:
- hypertension
- 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.
Locations and Contacts
Michel Azizi, MD, PhD, Phone: +33 (0) -1 56 09 29 12, Email: michel.azizi@egp.aphp.fr
Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou, Paris 75908 Cedex 15, France; Recruiting
Michel Azizi, MD, PhD, Phone: +33 (0)-1 56 09 29 12, Email: michel.azizi@egp.aphp.fr
Additional Information
Related publications: 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.
Starting date: March 2006
Ending date: March 2007
Last updated: March 14, 2007
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