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

September 19, 2008 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75908 Cedex 15
        • Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
treatment
Drug: high sodium diet
high sodium diet
Drug: low sodium diet
low sodium diet
Drug: ramipril 10 mg
ramipril 10 mg
Drug: valsartan 160 mg
valsartan 160 mg
Drug: candesartan 8 mg
candesartan 8 mg
Drug: atenolol 50 mg
atenolol 50 mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Michel Azizi, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 3, 2006

First Submitted That Met QC Criteria

April 3, 2006

First Posted (Estimate)

April 4, 2006

Study Record Updates

Last Update Posted (Estimate)

September 22, 2008

Last Update Submitted That Met QC Criteria

September 19, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P051201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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