- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00219076
A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients
May 16, 2017 updated by: Novartis
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
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.
Study Overview
Study Type
Interventional
Enrollment
504
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Investigative Centers, Germany
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New Jersey
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East Hanover, New Jersey, United States
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in mean sitting diastolic blood pressure after 6 weeks
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline in mean sitting systolic blood pressure after 6 weeks
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Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 6 weeks
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Achieve mean sitting blood pressure target of < 140/90 mmHg after 6 weeks
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Change from baseline in standing diastolic blood pressure after 6 weeks
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Change from baseline in standing systolic blood pressure after 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
October 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Actual)
May 18, 2017
Last Update Submitted That Met QC Criteria
May 16, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSPP100A2305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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NovartisCompleted