A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00219102
First received: September 12, 2005
Last updated: February 24, 2011
Last verified: February 2011
  Purpose

To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide


Condition Intervention Phase
Hypertension
Diabetes
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: A 12-week, Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in diastolic blood pressure after 12 weeks

Secondary Outcome Measures:
  • Change from baseline in systolic blood pressure after 12 weeks
  • Change from baseline in systolic and diastolic blood pressure after 6 weeks
  • Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks
  • Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks

Estimated Enrollment: 336
Study Start Date: June 2005
Study Completion Date: May 2007
Primary Completion Date: May 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 with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
  • Patients who are eligible and able to participate in the study

Exclusion Criteria

  • Severe hypertension
  • Uncontrolled diabetes type I and II
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219102

Locations
United States, North Carolina
Investigative Site
Salisbury,, North Carolina, United States, 28144
Belgium
Investigative Site
Kortrijk, Belgium
Romania
Investigative Site
Bucharest, Romania
Spain
Investigative Site
Madrid, Spain
Sweden
Investigative Site
Stockholm, Sweden
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Ukraine
Investigative Site
Kiev, Ukraine
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):
ClinicalTrials.gov Identifier: NCT00219102     History of Changes
Other Study ID Numbers: CSPP100A2310
Study First Received: September 12, 2005
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension,
diabetes,
aliskiren,
blood pressure,
valsartan,
hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on September 22, 2014