A Prospective, Randomized, Double-blind, Placebo-controlled, Evaluation of the Safety, Efficacy and Pharmacokinetics of MICARDIS® (Telmisartan) in Children and Adolescents With Hypertension After Four Weeks of Treatment

NCT02242344 Phase 2 COMPLETED

Study to assess the blood pressure lowering effects of two doses of telmisartan over a four-week treatment period; to determine potentially effective doses for pediatric patients for future studies; to assess the safety and tolerability of two doses of telmisartan. Pharmacokinetic objectives included the determination of the steady-state pharmacokinetics of telmisartan in children and adolescents aged 6 to \<18 years, and to determine if age-related differences exist

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	COMPLETED
Enrolment	77
Start date	2006-04

Conditions

• Hypertension

Interventions

• Telmisartan
• Placebo

Primary outcomes

• Change from baseline in seated systolic blood pressure (SBP) — Baseline, after 4 weeks of treatment