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

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ClinicalTrials.gov Identifier: NCT00424541
Recruitment Status : Completed
First Posted : January 19, 2007
Last Update Posted : November 29, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: SPP100 (aliskiren) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
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
Study Start Date : January 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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


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

ClinicalTrials.gov Identifier: NCT00424541     History of Changes
Other Study ID Numbers: CSPP100A1104
First Posted: January 19, 2007    Key Record Dates
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