A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: MK-8457; Drug: Placebo for MK-8457

Study type: Interventional

Funder types: Industry

Identifiers

NCT01446003

8457-004

Details and patient eligibility

About

This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic blood pressure in participants with mild to moderate hypertension in addition to safety and tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood pressure change from baseline after 10 days of dosing.

Enrollment: 31 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• If female, must be of non-childbearing potential
• If male with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
• Body mass index (BMI) ≤35 kg/m^2
• Mild-to-moderate hypertension requiring treatment with one or more antihypertensive agents
• Receiving stable treatment for hypertension for at least 8 weeks prior to the start of dosing and continuing therapy for duration of study
• No clinically significant arrhythmias or clinically significant abnormality on electrocardiogram
• Nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion criteria

• Any illness that might confound the results of the study or poses an additional risk
• History of stroke, chronic seizures, or major neurological disorder
• Clinically significant endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
• Clinically significant cardiovascular disease or has active angina
• History of malignant neoplastic disease
• Taking 325 mg aspirin daily
• Taking 3 or more medications for the treatment of hypertension
• Unable to refrain from or anticipates the use of any non-steroidal anti-inflammatory drugs (NSAIDs)
• Consumes excessive amounts of alcohol and/or coffee, tea, cola, or other caffeinated beverages
• Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks
• Significant multiple and/or severe allergies
• Regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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31 participants in 2 patient groups

MK-8457-Placebo Sequence

Experimental group

Description:

Participants received MK-8457 100 mg twice daily (BID) for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout.

Treatment:

Drug: MK-8457

Drug: Placebo for MK-8457

Placebo-MK-8457 Sequence

Experimental group

Description:

Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.

Treatment:

Drug: MK-8457

Drug: Placebo for MK-8457