Trial Outcomes & Findings for A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3) (NCT NCT01431508)

Last Updated: 2024-05-22

Results Overview

Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

At Baseline and Week 12

Results posted on

2024-05-22

Participant milestones
Measure	Losartan 50 mg / HCTZ 12.5 mg Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Losartan 50 mg / HCTZ 12.5 mg Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
Overall Study Lack of Efficacy	1
Overall Study Unable to Follow Protocol Procedures	1

A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)

Baseline characteristics by cohort
Measure	Losartan 50 mg / HCTZ 12.5 mg n=15 Participants Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
Age, Continuous	50.5 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

Timeframe: At Baseline and Week 12

Population: Intention-to-Treat

Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.

Outcome measures
Measure	Losartan 50 mg / HCTZ 12.5 mg n=15 Participants Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 Baseline (N = 15)	99.2 mm Hg Standard Deviation 5.5
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 Change from Baseline at Week 12 (N = 13)	-12.7 mm Hg Standard Deviation 3.2

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Losartan 50 mg/HCTZ 12.5 mg n=15 participants at risk
Cardiac disorders ARRHYTHMIA	6.7% 1/15 • Number of events 1
Cardiac disorders PALPITATIONS	6.7% 1/15 • Number of events 1
Gastrointestinal disorders ABDOMINAL DISTENSION	6.7% 1/15 • Number of events 1
Gastrointestinal disorders GASTRITIS	6.7% 1/15 • Number of events 1
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	6.7% 1/15 • Number of events 1
Investigations BLOOD CHOLESTEROL INCREASED	6.7% 1/15 • Number of events 1
Investigations BLOOD GLUCOSE ABNORMAL	13.3% 2/15 • Number of events 2
Investigations BLOOD POTASSIUM DECREASED	6.7% 1/15 • Number of events 1
Investigations BLOOD SODIUM INCREASED	6.7% 1/15 • Number of events 1
Investigations BLOOD TRIGLYCERIDES INCREASED	13.3% 2/15 • Number of events 2
Investigations BLOOD UREA INCREASED	6.7% 1/15 • Number of events 1
Investigations BLOOD URIC ACID INCREASED	20.0% 3/15 • Number of events 3
Musculoskeletal and connective tissue disorders MYALGIA	6.7% 1/15 • Number of events 1

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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