A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/7/2019 |
| Start Date: | October 25, 2011 |
| End Date: | March 3, 2012 |
A Multiple-Dose Clinical Trial to Study the Effect of MK-8457 on Ambulatory Blood Pressure in Hypertensive Patients
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.
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.
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
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