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Trial record 98 of 116 for:    Atenolol

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

Tracking Information
First Submitted Date  ICMJE April 3, 2006
First Posted Date  ICMJE April 4, 2006
Last Update Posted Date September 22, 2008
Study Start Date  ICMJE March 2006
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2006)
64
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00310778
Other Study ID Numbers  ICMJE P051201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabelle Brindel, Department Clinical Research of Developpement
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel Azizi, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP