Pharmacokinetic and Pharmacodynamic Profiles of Aliskiren in Japanese Patients With Mild to Moderate Essential Hypertension

Phase 1

Completed

• Conditions: Hypertension

• Registration Number: NCT00424541
• Lead Sponsor: Novartis

Brief Summary

This study will evaluate the pharmacokinetic profile, the effect of rennin inhibition and the relationship among pharmacokinetics, renin-angiotensin system (RAS) biomarkers, and blood pressure lowering effects of oral doses of SPP100 in Japanese patients with mild to moderate essential hypertension. Safety will also be evaluated.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-18
• Study First Submitted QC: 2007-01-18
• Study First Posted: 2007-01-19
• Study Completion: 2007-08
• Status Verified: 2007-11
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Japanese patients with mild to moderate essential hypertension aged 20 to 80 years

• Blood pressure: Mean (based on 3 recordings at 1-2 minute intervals) sitting diastolic blood pressure values on 14 days or 3 days before the treatment should meet the following criteria:

  • 14 days before treatment: ≥ 90 mmHg and < 110 mmHg
  • 3 days before treatment: ≥ 95 mmHg and < 110 mmHg
  • The difference in mean sitting diastolic blood pressure between 14 days and 3 days before the treatment is within 10 mmHg

• Body weight no less than 50 kg

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Exclusion Criteria

• Patients with mean (based on 3 recordings at 1-2 minute intervals) systolic blood pressure ≥ 180 mmHg and/or mean diastolic blood pressure ≥ 110 mmHg at Day -28, Day -14 and Day -3.
• Patients with or suspected of having secondary hypertension
• Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28

Secondary Outcome Measures

Name	Time	Method
safety
effect of aliskiren on the RAS profile
relationship among steady state pharmacokinetics, change in RAS biomarkers and blood pressure lowering effect of aliskiren

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Tokyo, Japan