A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazidebased Treatment Regimen With Optional Addition of Amlodipine

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
This study is designed to compare the long-term efficacy and safety of an aliskiren based regimen to an HCTZ based treatment regimen with optional addition of amlodipine in patients with essential hypertension.

Condition Intervention Phase
Drug: aliskiren
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Twenty Six-week, Randomized, Double-blind, Parallel Group, Multicenter, Active Controlled, Dose Titration Study to Evaluate the Efficacy and Safety of Aliskiren Compared to HCTZ With the Optional Addition of Amlodipine, Followed by a Second Twenty Six Weeks of Blinded Treatment, 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 26 weeks

Secondary Outcome Measures:
  • Change from baseline systolic blood pressure after 26 weeks
  • Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 26 weeks
  • Achieve blood pressure of < 140/90 mmHg after 26 weeks

Enrollment: 1125
Study Start Date: March 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

-Patients with essential hypertension

Exclusion Criteria:

  • Severe hypertension
  • History or evidence of a secondary form of hypertension
  • History of myocardial infarction. Other protocol-defined inclusion exclusion criteria also apply
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00219154

Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219154     History of Changes
Other Study ID Numbers: CSPP100A2323 
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 27, 2016