drugset / Trial / NCT01263314

Safety, Tolerability, and Pharmacokinetics of MK-8266 in Elderly Participants With High Blood Pressure (MK-8266-003)

NCT01263314 ↗

Phase 1 Completed 16 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled study. The hypothesis for this study is that single oral doses of MK-8266 selected for this study are sufficiently safe and well tolerated by elderly male and elderly female participants with hypertension to permit continued clinical investigation.

Timeline

Start
2010-11-01
Primary completion
2011-02-01
Completion
2011-03-01

Outcome

Mixed primary results

registry Panel B MK-8266 0.6 mg (Elderly Females, Mild/Moderate HTN) vs Panel B Placebo to MK-8266 (Elderly Fem., Mild/Moderate HTN); p = 0.0416; Mean Difference (Final Values) -10.1 (90% CI -19.6 to -0.56); ANOVA NCT01263314 ↗

registry Panel A MK-8266 0.3 mg (Elderly Males With Mild/Mod. HTN) vs Panel A Placebo to MK-8266 (Elderly Males Mild/Moderate HTN); p = 0.3551; Mean Difference (Final Values) -1.25 (90% CI -7.01 to 4.50); ANOVA NCT01263314 ↗

registry Panel A MK-8266 0.6 mg (Elderly Males With Mild/Mod. HTN) vs Panel A Placebo to MK-8266 (Elderly Males Mild/Moderate HTN); p = 0.0434; Mean Difference (Final Values) 4.12 (90% CI 0.18 to 8.05); ANOVA NCT01263314 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8266 Unknown 0.3 mg Oral
Subject MK-8266 Unknown 0.6 mg Oral
Subject MK-8266 Unknown 0.7 mg Oral

Indications