Status:
COMPLETED
A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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. Th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01446003
Start Date
October 25 2011
End Date
March 3 2012
Last Update
February 5 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Call for Information
Miramar, Florida, United States
2
Call for Information
Tacoma, Washington, United States