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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00310778 |
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 |
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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: | Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
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 |
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 |
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1: Experimental
treatment
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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
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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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
France | |
Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou | |
Paris, France, 75908 Cedex 15 |
Principal Investigator: | Michel Azizi, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Isabelle Brindel ) |
Study ID Numbers: | P051201 |
Study First Received: | April 3, 2006 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00310778 History of Changes |
Health Authority: | France: Ministry of Health |
High sodium diet Low sodium diet Renin-angiotensin system blockers AT1 receptor (AT1R) antagonist ACE inhibition |
Neurotransmitter Agents Ataxia-Telangiectasia Adrenergic Agents Healthy Cardiovascular Agents Angiotensin II Antihypertensive Agents Ramipril Protease Inhibitors Angiotensin II Type 1 Receptor Blockers |
Candesartan cilexetil Candesartan Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Ataxia Telangiectasia Peripheral Nervous System Agents Atenolol Valsartan |
Neurotransmitter Agents Sympatholytics Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Ramipril Pharmacologic Actions Protease Inhibitors Angiotensin II Type 1 Receptor Blockers |
Candesartan cilexetil Autonomic Agents Therapeutic Uses Candesartan Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Peripheral Nervous System Agents Atenolol Valsartan |