Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Tracking Information
Start Date ICMJE | March 2007 |
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Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 16, 2008) | Change in mean sitting systolic blood pressure (MSSBP) [ Time Frame: baseline to week 6 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: February 13, 2007) | Change from baseline is MSSBP at Week 6 |
Change History | Complete list of historical versions of study NCT00435162 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 16, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: February 13, 2007) |
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Descriptive Information
Brief Title ICMJE | Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure |
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Official Title ICMJE | A Randomized, Multicenter, Double-Blind, 6 Week Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 6 Months - 5 Years Old With Hypertension, Followed by a 2 Week Placebo Withdrawal Period. |
Brief Summary | The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension sitting systolic blood pressure [SSBP] ≥ 95th percentile ). |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Hypertension |
Intervention ICMJE | Drug: Valsartan |
Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 75 | ||||
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Estimated Completion Date | February 2009 | ||||
Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply | ||||
Gender | Both | ||||
Ages | 6 Months to 5 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Belgium, Brazil, Czech Republic, France, Germany, Hungary, India, Italy, Lithuania, Poland, Russian Federation, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00435162 | ||||
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Responsible Party | External Affairs, Novartis Pharmaceuticals | ||||
Study ID Numbers ICMJE | CVAL489K2303 | ||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Novartis |
Source: http://clinicaltrials.gov/