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Sponsored by: |
King Pharmaceuticals |
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Information provided by: | King Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00389519 |
The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension.
Condition | Intervention | Phase |
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Hypertension |
Drug: Ramipril |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Arm Study Assessing the Efficacy, Safety, and Dose-Response of Ramipril for the Treatment of Hypertension in Children and Adolescents |
Enrollment: | 242 |
Study Start Date: | October 2006 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years. Approximately 450 children will be given placebo, or 1 of the 3 doses of ramipril. The treatment assigned will be done by chance, like flipping a coin. Approximately 120 study centers throughout the world will participate in the trial.
Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drug(s), a 4-week Treatment Period where they will receive placebo or one of the ramipril doses, and a Follow-up visit 1 week after completion of the Treatment Period. Children diagnosed with hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (U.S. report), will be included in the study if their blood pressure meets certain values.
Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed. In addition, a child's parents/guardians will be instructed to measure their child's blood pressure at home between clinic visits.
A planned interim analysis was performed after approximately 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.
Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | K726-06-4003 |
Study First Received: | October 17, 2006 |
Last Updated: | February 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00389519 |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: Ministry of Health; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; India: Ministry of Health; Poland: Ministry of Health; South Africa: Medicines Control Council; Turkey: Ministry of Health; Ukraine: Ministry of Health |
Hypertension/*etiology Blood Pressure Pediatric Adolescent Child |
Vascular Diseases Ramipril Hypertension |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |