- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170976
A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension
October 11, 2023 updated by: Novartis
A 54 Week, Extension to the Double-blind, Multicenter, Multifactorial, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.
Study Overview
Study Type
Interventional
Enrollment (Actual)
403
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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Multiple Locations, Germany
- Sites in 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
Description
Inclusion Criteria:
- SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL
- VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg
Exclusion Criteria:
- PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE
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: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adverse events and serious adverse events at each study visit for 6 or 12 months
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline in diastolic blood pressure from baseline after 6 or 12 months
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Change from baseline in systolic blood pressure from baseline after 6 or 12 months
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Change from baseline in standing diastolic and systolic blood pressure after 6 or 12 months
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Change from baseline in sitting and standing pulse after 6 or 12 months
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Hematology and blood chemistry after 6 or 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
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
April 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 (Estimated)
September 15, 2005
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
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
- CVAA489A2307E1
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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