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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219037
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: June 2006
  Purpose

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 Intervention Phase
Hypertension
Drug: aliskiren
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Adverse events, laboratory abnormalities, serious adverse events

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

Enrollment: 1955
Study Start Date: June 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (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. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219037

Locations
Germany
Investigative Sites, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional 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
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension, blood pressure, aliskiren

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 April 22, 2014