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A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: November 30, 2005
Last updated: November 7, 2011
Last verified: November 2011
This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks

Condition Intervention Phase
Drug: aliskiren
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension

Resource links provided by NLM:

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Change from baseline in systolic blood pressure after 8 weeks
  • Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 8 weeks

Enrollment: 641
Study Start Date: November 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Male and female outpatients 18 years of age and older
  • Patients who are eligible and able to participate in the study

Exclusion Criteria:

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply

  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 identifier: NCT00260923

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Investigative Centers, Germany
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Sponsor GmbH
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00260923     History of Changes
Other Study ID Numbers: CSPP100A2328 
Study First Received: November 30, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on October 25, 2016