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

• Status: Completed
• Trial end date: 2012-03-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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