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

• ClinicalTrials.gov Identifier: NCT00310778
• Recruitment Status: Completed
• First Posted: April 4, 2006
• Last Update Posted: September 22, 2008
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by: Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: April 3, 2006
• First Posted Date: April 4, 2006
• Last Update Posted Date: September 22, 2008
• Study Start Date: March 2006
• Actual Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 19, 2008): 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 ]
• Original Primary Outcome Measures (submitted: April 3, 2006): Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion
• Change History: Complete list of historical versions of study NCT00310778 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
• 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
• 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.
• 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
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Healthy

Intervention

• 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

Study Arms

Experimental: 1

treatment

Interventions:

• Drug: high sodium diet
• Drug: low sodium diet
• Drug: ramipril 10 mg
• Drug: valsartan 160 mg
• Drug: candesartan 8 mg
• Drug: atenolol 50 mg

• Publications *: Azizi M, Ménard J, Bissery A, Guyenne TT, Bura-Rivière 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 3, 2006): 64
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2007
• Actual Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00310778
• Other Study ID Numbers: P051201
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Isabelle Brindel, Department Clinical Research of Developpement
• Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

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

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: September 2008