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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00424541
First received: January 18, 2007
Last updated: November 28, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: SPP100 (aliskiren)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multiple Center, Randomized, Double Blind, Parallel Group, Multiple Oral Doses Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profiles of 150 mg and 300 mg of SPP100 in Japanese Patients With Mild to Moderate Essential Hypertension

Resource links provided by NLM:

Drug Information available for: Aliskiren
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • pharmacokinetic profile of aliskiren administration after meal Day 1, Day 14, and Day 28

Secondary Outcome Measures:
  • effect of aliskiren on the RAS profile
  • relationship among steady state pharmacokinetics, change in RAS biomarkers and blood pressure lowering effect of aliskiren
  • safety

Estimated Enrollment: 34
Study Start Date: January 2007
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424541

Locations
Japan
Novartis Investigative Site
Tokyo, Japan, 160-8618
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative Site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00424541     History of Changes
Other Study ID Numbers: CSPP100A1104
Study First Received: January 18, 2007
Last Updated: November 28, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Pharmacokinetics, pharmacodynamics, safety, RAS profile, SPP100, aliskiren, Japanese, essential hypertension
Mild to moderate essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013