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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219154
First Posted: September 22, 2005
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
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
Hypertension Drug: aliskiren Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT00219154


Locations
Germany
Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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
First Submitted: September 12, 2005
First Posted: September 22, 2005
Last Update Posted: November 8, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents