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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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171405
First received: August 24, 2005
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Hypertension
 Drug: aliskiren
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Estimated Enrollment: 250
Study Start Date: June 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00171405     History of Changes
Other Study ID Numbers: CSPP100A2302E1
Study First Received: August 24, 2005
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
hypertension
aliskiren
hydrochlorothiazide

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

ClinicalTrials.gov processed this record on May 16, 2013