A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)
NCT ID: NCT01446003
Last Updated: 2019-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2011-10-25
2012-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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MK-8457-Placebo Sequence
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.
MK-8457
10 x 10-mg capsule BID for 10 days
Placebo for MK-8457
10 x 10-mg capsule BID for 10 days
Placebo-MK-8457 Sequence
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.
MK-8457
10 x 10-mg capsule BID for 10 days
Placebo for MK-8457
10 x 10-mg capsule BID for 10 days
Interventions
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MK-8457
10 x 10-mg capsule BID for 10 days
Placebo for MK-8457
10 x 10-mg capsule BID for 10 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Call for Information
Miramar, Florida, United States
Call for Information
Tacoma, Washington, United States
Countries
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Other Identifiers
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8457-004
Identifier Type: -
Identifier Source: org_study_id
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