- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00171028
A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension
November 7, 2011 updated by: Novartis
A Double-Blind, Randomized, Multi-Center Study Followed By 12 Months Open-Label Treatment To Evaluate The Dose Response And Safety Of Valsartan In Pediatric Hypertension Patients 1 - 5 Years Of Age
Drugs used to treat hypertension in adults should also be effective in treating high blood pressure in infants and children.
This study will test the safety and efficacy of valsartan in lowering blood pressure in children 1 - 5 years old whose parents grant permission to participate.
Study Overview
Study Type
Interventional
Enrollment (Actual)
90
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
-
-
New Jersey
-
E. Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
-
-
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
1 year to 5 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- CHILDREN HAVE BLOOD PRESSURE LEVEL =>95TH PERCENTILE FOR AGE,GENDER & HEIGHT
- PARENTAL CONSENT MUST BE GRANTED
Exclusion Criteria:
- BLOOD PESSURE IS =>25% HIGHER THAN 95TH PERCENTILE FOR AGE, GENDER & HEIGHT
- SERIOUS, CLINICALLY SIGNIFICANT FINDINGS UPON EXAMINATION AND LABORATORY OR OTHER ASSESSMENTS
Other protocol-defined exclusion criteria will 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 |
---|
Change from baseline systolic blood pressure after 2 and 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
Change from baseline systolic blood pressure after 4 weeks
|
Change from baseline diastolic blood pressure after 2 weeks
|
Change in 2 week diastolic blood pressure after 2 more weeks
|
Change in baseline diastolic blood pressure after 4 weeks
|
Adverse events, serious adverse events, and laboratory values during 4 weeks
|
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
December 1, 2003
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 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 (Estimate)
November 8, 2011
Last Update Submitted That Met QC Criteria
November 7, 2011
Last Verified
June 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVAL489A2307
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.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
Clinical Trials on valsartan
-
Qingdao Central HospitalNot yet recruitingMyocardial Infarction | HypertensionChina
-
Novartis PharmaceuticalsCompleted
-
Damanhour UniversityTanta UniversityCompleted
-
Yuhan CorporationCompletedHypertension | HyperlipidemiaKorea, Republic of
-
Novartis PharmaceuticalsCompletedHeart Failure With Preserved Ejection Fraction (HFpEF)United States, Canada
-
Novartis PharmaceuticalsCompletedHypertensionSweden, Belgium, Hungary, India, Italy, Poland, Turkey, United States, Brazil, France, South Africa
-
University of Alabama at BirminghamNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular Diseases | Diabetes Mellitus | Insulin Sensitivity/Resistance | Metabolic Disease | Energy Expenditure | Metabolism | Natriuretic PeptidesUnited States
-
University of Alabama at BirminghamNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular Diseases | Hypertension | Obesity | Nocturnal Blood Pressure | Natriuretic Peptides | Renin-Angiotensin-Aldosterone SystemUnited States
-
Shanghai Pharmaceuticals Holding Co., LtdRecruitingDiabetic Kidney DiseaseChina
-
NovartisCompleted