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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00219076
First received: September 12, 2005
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

To evaluate the blood pressure lowering effect and safety of aliskiren 150 mg used in combination with amlodipine 5 mg in patients with essential hypertension not adequately responsive to amlodipine 5 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: A Six-Week, Randomized, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren 150 mg and Amlodipine 5 mg Compared to Amlodipine 5 mg and 10 mg in Hypertensive Patients Not Adequately Responsive to Amlodipine 5 mg

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in mean sitting diastolic blood pressure after 6 weeks

Secondary Outcome Measures:
  • Change from baseline in mean sitting systolic blood pressure after 6 weeks
  • Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks
  • Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks
  • Change from baseline in standing diastolic blood pressure after 6 weeks
  • Change from baseline in standing systolic blood pressure after 6 weeks

Estimated Enrollment: 504
Study Start Date: February 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

  • 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
  • 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: NCT00219076

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

No publications provided

ClinicalTrials.gov Identifier: NCT00219076     History of Changes
Other Study ID Numbers: CSPP100A2305
Study First Received: September 12, 2005
Last Updated: September 25, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, amlodipine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 23, 2014