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

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ClinicalTrials.gov Identifier: NCT00219076
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 18, 2017
Sponsor:
Information provided by:
Novartis

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: aliskiren Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2005
Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00219076     History of Changes
Other Study ID Numbers: CSPP100A2305
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

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

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