SPP100 Dose Finding Study in Japan

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00311012
First received: March 31, 2006
Last updated: November 7, 2011
Last verified: June 2006
  Purpose

This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.


Condition Intervention Phase
Hypertension
Drug: Aliskiren
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dose-finding Study of SPP100 in Essential Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcome Measures:
  • Change from baseline in mean sitting systolic blood pressure after 8 weeks
  • Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks
  • Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks

Enrollment: 445
Study Start Date: August 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  1. Mild to moderate essential hypertension
  2. Age: ≥20 years old and <80 years old (at time informed consent obtained)
  3. Sex: N/A
  4. Admission status: Outpatient

Exclusion Criteria:

  1. Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
  2. Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
  3. Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
  4. Patients suspected of having malignant hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311012

Locations
Japan
Novartis Pharmaceuticals
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Pharmaceuticals, Japan Novartis Pharmaceuticals, Japan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00311012     History of Changes
Other Study ID Numbers: CSPP100A1201
Study First Received: March 31, 2006
Last Updated: November 7, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Hypertension, Aliskiren

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014