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A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

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: NCT00171405
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 18, 2016
Information provided by:

Brief Summary:
The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 4 Month Extension to 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 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study

Secondary Outcome Measures :
  1. Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months
  2. Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months
  3. Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months
  4. Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline
  5. Blood pressure less than 140/90 mmHg

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
  2. absence of ongoing severe adverse events at Visit 10.

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): NCT00171405

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United States, New Jersey
Investigative Site
East Hanover, New Jersey, United States
Investigative Site
Deurne, Belgium
Investigative Site
Ste-Fov, Canada
Investigative Site
Krassel, Germany
Investigative Site
Broni, Italy
Investigative Site
Rotterdam, Netherlands
Investigative Site
Lima, Peru
Russian Federation
Investigative Site
Moscow, Russian Federation
Investigative Site
Basel, Switzerland
United Kingdom
Investigative Site
London, United Kingdom
Sponsors and Collaborators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00171405    
Other Study ID Numbers: CSPP100A2302E1
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases