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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:
ClinicalTrials.gov Identifier:
NCT00424541
First Posted: January 19, 2007
Last Update Posted: November 29, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424541


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

ClinicalTrials.gov Identifier: NCT00424541     History of Changes
Other Study ID Numbers: CSPP100A1104
First Submitted: January 18, 2007
First Posted: January 19, 2007
Last Update Posted: November 29, 2007
Last Verified: November 2007

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