- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171080
VALID: Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan Compared to Irbesartan in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis
May 16, 2017 updated by: Novartis
A 2 x 5-week Multicenter, Cross-over Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan 80 mg Compared to Irbesartan 150 mg in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis
The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80 mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in patients on long-term haemodialysis with mild to moderate increased mean supine systolic blood pressure (MSSBP).
Study Overview
Study Type
Interventional
Enrollment (Actual)
86
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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with mild and moderate hypertension defined by a MSSBP ≥ 140 mmHG and < 180 mmHG at Visits 1 and 2 for treated and untreated patients
- Chronic hemodialysis for at least 6 months prior to Visit 1 as substitution therapy.
- If treated with epoetin: patients with a stable hematocrit ≤ 40% (± 5%).
Exclusion Criteria:
- Inability to discontinue angiotensin II receptor blockers (ARBs) safely for a period of 1 week, as required by the protocol.
- Treatment with more than 3 different compounds for the treatment of hypertension at Visit 1.
- Atrial fibrillation
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: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline in systolic blood pressure after 4 weeks
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Secondary Outcome Measures
Outcome Measure |
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Change from baseline in diastolic blood pressure after 4 weeks
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Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure
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Adverse events and clinical laboratory abnormal results
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Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks
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Change from baseline in daytime and nighttime ambulatory blood pressures after 4 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
April 1, 2004
Primary Completion (Actual)
March 1, 2006
Study Completion (Actual)
March 1, 2006
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 18, 2017
Last Update Submitted That Met QC Criteria
May 16, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVAL489ADE19
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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SanofiCompleted
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Travere Therapeutics, Inc.Active, not recruitingImmunoglobulin A NephropathyUnited States, Australia, Belgium, Croatia, Czechia, Estonia, France, Germany, Hong Kong, Italy, Korea, Republic of, Lithuania, New Zealand, Poland, Portugal, Spain, Taiwan, United Kingdom
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University of Southern DenmarkBristol-Myers SquibbCompleted
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Jiangsu Famous Medical Technology Co., Ltd.Unknown