- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386139
A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients
February 3, 2017 updated by: Novartis
An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (300/12.5 mg and 300/25 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.
Study Overview
Study Type
Interventional
Enrollment (Actual)
881
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, 07936
- 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:
- Male or female outpatients 18 years old or older.
- Patients with a diagnosis of hypertension.
- Patients who are eligible and consent to participate in the study
Exclusion Criteria:
- Severe hypertension
- Previous or current diagnosis of heart failure.
- History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
- Other protocol-defined inclusion/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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Mean Sitting Diastolic Blood Pressure lowering effect at baseline, and week 8.
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Secondary Outcome Measures
Outcome Measure |
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Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
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Safety and tolerability
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Proportion of patients achieving a blood pressure control target at week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2006
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
October 9, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (Estimate)
October 11, 2006
Study Record Updates
Last Update Posted (Estimate)
February 7, 2017
Last Update Submitted That Met QC Criteria
February 3, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSPP100A2332
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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Clinical Trials on Aliskiren/HCTZ
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Vanderbilt University Medical CenterCompletedHigh Blood PressureUnited States
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NovartisCompletedHypertensionUnited States, Germany
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NovartisCompleted
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Novartis PharmaceuticalsTerminatedNon-diabetic NephropathyNetherlands
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NovartisCompletedHypertensionSwitzerland, Italy, Argentina, Germany, Turkey, United States, Ecuador, Guatemala
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Novartis PharmaceuticalsTerminatedCardiovascular EventsColombia, India, South Africa, Canada, Spain, Hungary, United States, Germany, Ireland, Argentina, Philippines, Brazil, Sweden, Malaysia, Chile, Israel, Czech Republic, Netherlands
-
NovartisCompleted
-
NovartisCompleted
-
NovartisCompletedHypertensionSlovakia, Italy, Netherlands, Argentina, Germany, Poland, Czech Republic, Iceland
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NovartisCompletedEssential HypertensionGermany, Spain, United States