drugset / Trial / NCT01130168

The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)

NCT01130168 ↗

Phase 1 Completed 38 enrolled Merck Sharp & Dohme LLC
RandomizedCrossoverDouble-blindTreatment

Summary

This study will test the relationship between CBP (central blood pressure) and PBP (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.

Timeline

Start
2010-05
Primary completion
2010-11
Completion
2010-11

Outcome

Mixed primary results

registry analysis (superiority or other test); ISMN ER vs Placebo; p <0.0005; Mean Difference (Final Values) -13.1 (95% CI -15.3 to -10.9); ANOVA NCT01130168 ↗

registry analysis (superiority or other test); ISMN ER vs Placebo; p = 0.407; Mean Difference (Final Values) 1.3 (95% CI -1.7 to 4.3); ANOVA NCT01130168 ↗

registry analysis (superiority or other test); Amlodipine vs Placebo; p <0.0005; Mean Difference (Final Values) -5.9 (95% CI -8.9 to -2.9); ANOVA NCT01130168 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Amlodipine Other / unclassified 10 mg Oral
Subject Isosorbide Mononitrate Other / unclassified 30 mg Oral

Indications