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

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00310778

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 I

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:

Drug Information available for: Atenolol Ramipril Valsartan CV 11974 Candesartan cilexetil

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

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:

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.

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 February 09, 2012