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Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension

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.
ClinicalTrials.gov Identifier: NCT00219037
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.

Condition or disease Intervention/treatment Phase
Hypertension Drug: aliskiren Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1955 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension.
Study Start Date : June 2004
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Adverse events, laboratory abnormalities, serious adverse events

Secondary Outcome Measures :
  1. Change from baseline in mean sitting diastolic blood pressure after 12 months
  2. Change from baseline in mean sitting systolic blood pressure after 12 months
  3. Change from baseline in standing systolic blood and diastolic pressure after 12 months
  4. Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline
  5. Blood pressure less than 140/90 mmHg

Eligibility Criteria

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

Inclusion Criteria

  1. Patients with essential hypertension.
  2. Patients who are eligible and able to participate in the study.

Exclusion Criteria

  1. Severe hypertension.
  2. History or evidence of a secondary form of hypertension.
  3. History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may 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): NCT00219037

Investigative Sites, Germany
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: NCT00219037     History of Changes
Other Study ID Numbers: CSPP100A2302
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: June 2006

Keywords provided by Novartis:
Hypertension, blood pressure, aliskiren

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