Clinical trial NCT01096160
Conditions: Hypertension
Keywords: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-03-01; Completion date: 2010-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.

Detailed description:
This study evaluated AEs, discontinuation due to AEs, and effects on hemodynamic parameters, including systolic blood pressure (SBP) and aortic augmentation index (AIx), following multiple oral doses of MK-8266. Five serial panels, each consisting of eight participants (40 participants in Panels A, B, C, D, and E), were randomized to receive either MK-8266 or matching placebo twice daily (BID) or three times daily (TID) for 10 consecutive days. Although the original plan was to evaluate MK-8266 treatment in Panels D and E using both BID and TID regimens, the study actually evaluated identical TID regimens in these panels.

Arms: arm 1: MK-8266 1 mg (0.7 mg in the morning \[AM\] + 0.3 mg in the evening \[PM\]), or as matching placebo BID. arm 2: MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID. arm 3: MK-8266 TID, 1.8 mg (0.6 mg every 6 hours \[q6hr\]), or as matching placebo TID. arm 4: MK-8266 TID (Panel D), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel D was completed prior to initiation of Panel E. arm 5: MK-8266 TID (Panel E), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel E was initiated after completion of Panel D.
Interventions: intervention 1: MK-8226 BID, 1 mg intervention 2: MK-8266 BID, 1.8 mg intervention 3: MK-8266 TID, 1.8 mg intervention 4: MK-8266 TID, 2.4 mg intervention 5: MK-8266 TID, 2.4 mg intervention 6: Placebo BID (Panel A) intervention 7: Placebo BID (Panel B) intervention 8: Placebo TID (Panel C) intervention 9: Placebo TID (Panel D) intervention 10: Placebo TID (Panel E)
Intervention descriptions: intervention 1: MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. intervention 2: MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C. intervention 3: MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D. intervention 4: MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E. intervention 5: MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D. intervention 6: Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. intervention 7: Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C. intervention 8: Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D. intervention 9: Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E. intervention 10: Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.

Protocol documents: