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

NCT00310778 | Completed Phase 1 DMC

• 1 other identifier: P051201
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

High sodium diet; Low sodium diet; Renin-angiotensin system blockers; AT1 receptor (AT1R) antagonist; ACE inhibition

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) up to the 48 hour time point of plasma drug concentrations between a replated-sodium diet and sodium depletion

  48 hours

Study Arms (1)

1

EXPERIMENTAL

treatment

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

Interventions

high sodium diet DRUG

high sodium diet

1

low sodium diet DRUG

low sodium diet

1

ramipril 10 mg DRUG

ramipril 10 mg

1

valsartan 160 mg DRUG

valsartan 160 mg

1

candesartan 8 mg DRUG

candesartan 8 mg

1

atenolol 50 mg DRUG

atenolol 50 mg

1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou

Paris, 75908 Cedex 15, France

Location

Related Publications (1)

• 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. doi: 10.1097/01.ASN.0000146686.35541.29.

  PMID: 15579516 BACKGROUND

MeSH Terms

Interventions

Diet, Sodium-Restricted; Ramipril; Valsartan; candesartan; Atenolol

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Michel Azizi, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 4, 2006
• Study Start: March 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: September 22, 2008

Record last verified: 2008-09

Locations

FR (1)