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

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ClinicalTrials.gov Identifier: NCT00310778
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : September 22, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: high sodium diet Drug: low sodium diet Drug: ramipril 10 mg Drug: valsartan 160 mg Drug: candesartan 8 mg Drug: atenolol 50 mg Phase 1

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  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310778


Locations
France
Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou
Paris, France, 75908 Cedex 15
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Michel Azizi, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
Responsible Party: Isabelle Brindel, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00310778     History of Changes
Other Study ID Numbers: P051201
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: September 22, 2008
Last Verified: September 2008

Keywords provided by Assistance Publique - Hôpitaux de Paris:
High sodium diet
Low sodium diet
Renin-angiotensin system blockers
AT1 receptor (AT1R) antagonist
ACE inhibition

Additional relevant MeSH terms:
Candesartan
Candesartan cilexetil
Valsartan
Ramipril
Atenolol
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents