Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: high sodium diet; Drug: low sodium diet; Drug: ramipril 10 mg; Drug: valsartan 160 mg; Drug: candesartan 8 mg; Drug: atenolol 50 mg

• Registration Number: NCT00310778
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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 blockers such as AT1R antagonists and angiotensin converting enzyme inhibitors.

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-04
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-19
• Last Update Posted: 2008-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	ramipril 10 mg	treatment
1	valsartan 160 mg	treatment
1	candesartan 8 mg	treatment
1	atenolol 50 mg	treatment
1	high sodium diet	treatment
1	low sodium diet	treatment

Primary Outcome Measures

Name	Time	Method
Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion	48 hours

Trial Locations

Locations (1)

Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France