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

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. Identifier: NCT00294710
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Twenty Six-week, 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
Study Start Date : March 2005
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 52 weeks

Secondary Outcome Measures :
  1. Change from baseline in systolic and diastolic blood pressure after 52 weeks
  2. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks
  3. Achieve blood pressure control target of < 140/90 mmHg after 12 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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 identifier (NCT number): NCT00294710

United States, New Jersey
East Hanover, New Jersey, United States, 07936
Investigative Centers, Germany
Sponsors and Collaborators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00294710     History of Changes
Other Study ID Numbers: CSPP100A2323E
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Novartis:
Hypertension, aliskiren, hydrochlorothiazide, amlodipine

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors