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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01446003
First received: September 30, 2011
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: MK-8457
Drug: Placebo for MK-8457
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multiple-Dose Clinical Trial to Study the Effect of MK-8457 on Ambulatory Blood Pressure in Hypertensive Patients

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline to Day 10 in 24-hour mean ambulatory systolic blood pressure [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline to Day 10 in 24-hour mean ambulatory diastolic blood pressure [ Time Frame: Baseline and Day 10 ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Day 10 in Maximum Moving Average (maxMAΔ) Blood Pressure Measured over 4 hours [ Time Frame: Up to 4 hours postdose on Days 1 and 10 ] [ Designated as safety issue: Yes ]
  • Area under the plasma concentration versus time curve from 0 to 12 hours (AUC0-12hr) [ Time Frame: Predose and up to 12 hours postdose on Days 1 and 10 ] [ Designated as safety issue: No ]
  • Maximum concentration (Cmax) of MK-8457 in the plasma [ Time Frame: Predose and up to 12 hours postdose on Days 1 and 10 ] [ Designated as safety issue: No ]
  • Time to reach Cmax (Tmax) [ Time Frame: Predose and up to 12 hours postdose on Days 1 and 10 ] [ Designated as safety issue: No ]
  • Trough plasma concentration (Ctrough) of MK-8457 [ Time Frame: Predose and up to 12 hours postdose on Days 1 and 10 ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: November 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-8457-Placebo Sequence
Each treatment will be separated by a 10-day washout
Drug: MK-8457
10 x 10-mg capsule twice daily (BID) for 10 days
Drug: Placebo for MK-8457
10 x 10-mg capsule BID for 10 days
Experimental: Placebo-MK-8457 Sequence
Each treatment will be separated by a 10-day washout
Drug: MK-8457
10 x 10-mg capsule twice daily (BID) for 10 days
Drug: Placebo for MK-8457
10 x 10-mg capsule BID for 10 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446003

Locations
United States, Florida
Call for Information
Miramar, Florida, United States
United States, Washington
Call for Information
Tacoma, Washington, United States
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01446003     History of Changes
Other Study ID Numbers: MK-8457-004
Study First Received: September 30, 2011
Last Updated: April 3, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014