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.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: September 25, 2008
Last verified: September 2008
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
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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00219076

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

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:
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on April 27, 2016