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A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219193
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg


Condition Intervention Phase
Hypertension
 Drug: aliskiren
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Eight Week, Multicenter Study to Evaluate Efficacy and Safety of the Triple Combo of Aliskiren /Valsartan/HCTZ (300/320/25 mg), Compared to the Double Combos of Aliskiren/HCTZ (300/25 mg) or Valsartan/HCTZ (320/25 mg) in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures:
  • Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks
  • Change from baseline in standing blood pressure after 4 weeks and 8 weeks
  • Achieve blood pressure control target of < 140/90 mmHg after 8 weeks

Enrollment: 641
Study Start Date: October 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (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

  • Patients with essential hypertension
  • Patients who are eligible and able to participate in the study

Exclusion Criteria

  • Severe hypertension
  • History or evidence of a secondary form of hypertension

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00219193

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany
Investigative Centers, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219193     History of Changes
Other Study ID Numbers: CSPP100A2331
Study First Received: September 12, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, valsartan, HCTZ

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013