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SPP100 Dose Finding Study in Japan

This study has been completed.
Information provided by:
Novartis Identifier:
First received: March 31, 2006
Last updated: November 7, 2011
Last verified: June 2006
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
Intervention Model: Parallel Assignment
Masking: Double
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)

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00311012

Novartis Pharmaceuticals
Tokyo, Japan
Sponsors and Collaborators
Principal Investigator: Novartis Pharmaceuticals, Japan Novartis Pharmaceuticals, Japan
  More Information Identifier: NCT00311012     History of Changes
Other Study ID Numbers: CSPP100A1201
Study First Received: March 31, 2006
Last Updated: November 7, 2011

Keywords provided by Novartis:
Hypertension, Aliskiren

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on August 18, 2017