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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

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ClinicalTrials.gov Identifier: NCT00171405
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 18, 2016
Sponsor:
Information provided by:
Novartis

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

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00171405


Locations
United States, New Jersey
Investigative Site
East Hanover, New Jersey, United States
Belgium
Investigative Site
Deurne, Belgium
Canada
Investigative Site
Ste-Fov, Canada
Germany
Investigative Site
Krassel, Germany
Italy
Investigative Site
Broni, Italy
Netherlands
Investigative Site
Rotterdam, Netherlands
Peru
Investigative Site
Lima, Peru
Russian Federation
Investigative Site
Moscow, Russian Federation
Switzerland
Investigative Site
Basel, Switzerland
United Kingdom
Investigative Site
London, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00171405     History of Changes
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:
hypertension
aliskiren
hydrochlorothiazide

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