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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT01446003

Run by

Merck Sharp & Dohme LLC

People needed

31

Starts

2011-10-25

Expected to finish

2012-03-03

Last updated by the study team

2019-02-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Call for Information — Miramar, Florida, United States
• Call for Information — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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