Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00310778
First received: April 3, 2006
Last updated: September 19, 2008
Last verified: September 2008
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: March 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
treatment
 Drug: high sodium diet
high sodium diet
Other Name: high sodium diet
Drug: low sodium diet
low sodium diet
Other Name: low sodium diet
Drug: ramipril 10 mg
ramipril 10 mg
Other Name: ramipril 10 mg
Drug: valsartan 160 mg
valsartan 160 mg
Other Name: valsartan 160 mg
Drug: candesartan 8 mg
candesartan 8 mg
Other Name: candesartan 8 mg
Drug: atenolol 50 mg
atenolol 50 mg
Other Name: atenolol 50 mg

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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Isabelle Brindel, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00310778     History of Changes
Other Study ID Numbers: P051201
Study First Received: April 3, 2006
Last Updated: September 19, 2008
Health Authority: France: Ministry of Health

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:
Atenolol
Candesartan
Candesartan cilexetil
Valsartan
Ramipril
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive 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
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013