Phase 1 N=31 Randomized Triple-blind Treatment

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

Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01446003 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Change From Baseline to Day 10 in 24-hour Mean Ambulatory Systolic Blood Pressure (SBP) — -0.47; -2.49 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: MK-8457 (Drug); Placebo for MK-8457 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Day 10 in 24-hour Mean Ambulatory Systolic Blood Pressure (SBP)	-0.47; -2.49	—
PRIMARY Number of Participants Who Experienced at Least One Adverse Event (AE)	8; 9	—
PRIMARY Number of Participants Who Discontinued the Study Medication Due to an AE	1; 0	—
SECONDARY Change From Baseline to Day 10 in 24-hour Mean Ambulatory Diastolic Blood Pressure (DBP)	0.22; -1.35	—
SECONDARY Change From Baseline to Day 10 in Maximum Moving Average (maxMAΔ) Blood Pressure Measured Over 4 Hours	17.80; 9.90; 12.68; 13.61; 16.90; 11.64	—
SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12hr) of MK-8457	29600; 56200	—
SECONDARY Maximum Concentration (Cmax) of MK-8457	5680; 8630	—
SECONDARY Time to Maximum Concentration (Tmax) of MK-8457	1; 1	—
SECONDARY Trough Plasma Concentration (Ctrough) of MK-8457	999; 2540	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01446003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.