- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170963
Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone
May 15, 2017 updated by: Novartis
Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 mg Monotherapy
This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication
Study Overview
Study Type
Interventional
Enrollment (Actual)
1018
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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Basel, Switzerland
- 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
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with uncomplicated, essential hypertension
Exclusion Criteria:
- Severe hypertension
- History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
- Liver, kidney, or pancreas disease
- Insulin dependent diabetes
- Allergy to certain medications used to treat high blood pressure
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 diastolic blood pressure after 8 weeks
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline in mean systolic blood pressure after 8 weeks
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Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was less than 90 mmHg after 8 weeks
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Diastolic blood pressure less than 90 mmHg after 8 weeks
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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
October 1, 2004
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
September 10, 2005
First Submitted That Met QC Criteria
September 10, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
May 17, 2017
Last Update Submitted That Met QC Criteria
May 15, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Amlodipine
- Valsartan
Other Study ID Numbers
- CVAA489A2305
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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