Trial Outcomes & Findings for MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352) (NCT NCT01307046)

Results Overview

Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

336 participants

Primary outcome timeframe

Baseline and Week 8

Results posted on

2024-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	MK-0954A Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.	Losartan Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Overall Study STARTED	166	170
Overall Study COMPLETED	154	159
Overall Study NOT COMPLETED	12	11

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-0954A Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.	Losartan Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Overall Study Adverse Event	3	3
Overall Study Lack of Efficacy	0	2
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	1	1
Overall Study Serum Potassium Withdrawal Criteria Met	4	2
Overall Study Blood Pressure Withdrawal Criteria Met	2	3

Baseline Characteristics

MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-0954A n=166 Participants Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.	Losartan n=170 Participants Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.	Total n=336 Participants Total of all reporting groups
Age, Continuous	55.7 years STANDARD_DEVIATION 9.2 • n=5 Participants	54.9 years STANDARD_DEVIATION 9.5 • n=7 Participants	55.3 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	60 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants	110 Participants n=7 Participants	239 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 8

Population: Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data

Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).

Outcome measures

Outcome measures
Measure	MK-0954A n=166 Participants Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.	Losartan n=170 Participants Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)	-8.7 mmHg 95% Confidence Interval 0.6 • Interval -9.9 to -7.6	-3.6 mmHg 95% Confidence Interval 0.6 • Interval -4.8 to -2.5

PRIMARY outcome

Timeframe: 8 weeks

Population: All-Patients-as-Treated (APaT) Population: defined as all randomized participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	MK-0954A n=166 Participants Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.	Losartan n=170 Participants Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Percentage of Participants Who Experienced at Least One Adverse Event (AE)	31.3 percentage of participants	26.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: Full Analysis Set (FAS) Population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data

Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).

Outcome measures

Outcome measures
Measure	MK-0954A n=166 Participants Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.	Losartan n=170 Participants Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)	-14.5 mmHg Interval -16.5 to -12.6	-5.4 mmHg Interval -7.3 to -3.4

Adverse Events

MK-0954A

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Losartan

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MK-0954A n=166 participants at risk Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.	Losartan n=170 participants at risk Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
Infections and infestations Nasopharyngitis	5.4% 9/166 • Number of events 11	5.3% 9/170 • Number of events 10

Additional Information

Senior Vice President, Global Clinical Development

Merch Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. The sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER