CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 362 enrolled
Drug / intervention
olmesartan medoxomil +2 moredrug
Likely dose
Olmesartan medoxomil 2.5–40 mg daily (dosing based on weight and age; Cohort C: 0.3–0.6 mg/kg daily)AI-extracted
Key inclusion· 3
  • ✓Seated systolic BP ≥95th percentile for gender and height-for-age, or ≥90th percentile if diabetic, with kidney disease, or family history of hypertension
  • ✓Negative for hepatitis B and C
  • ✓Negative for HIV
Key exclusion· 8
  • ✕Known sensitivity or allergy to olmesartan medoxomil
  • ✕Malignant hypertension
  • ✕History of congestive heart failure, cardiomyopathy, or obstructive valve disease
  • ✕Renal transplant within previous 6 months

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00151775
NCT00151775Phase 3Completed
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Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Daiichi Sankyo·interventional·Posted Sep 9, 2005·Updated Jun 30, 2016

In Brief

A Phase 3 clinical trial evaluating olmesartan medoxomil and placebo for Hypertension. Completed, enrolled 362 participants across 65 sites in 11 countries.

Detailed Summary

This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesArgentina, Brazil, Chile, Colombia, India, Kenya, Peru, South Africa, Uganda, United States, Zambia
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2005
Enrollment StartMay 1, 2005
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

olmesartan medoxomildrug

Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension. Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily

placebodrug

Cohorts A, B, C: placebo, once daily

olmesartan medoxomildrug

Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly. Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg