Status:
COMPLETED
Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hypertension
Eligibility:
MALE
21-60 years
Phase:
PHASE1
Brief Summary
This was designed as a two part study comprising sequential double-dummy, placebo controlled 3-period randomized crossover studies. The study will evaluate the safety, tolerability, pharmacokinetics, ...
Eligibility Criteria
Inclusion
- Participant has essential hypertension who is in grade 1 or 2 hypertension according to the European Society of Hypertension (ESH) as delineated in the European Society of Cardiology (ESC) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study.
- Otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated with a single antihypertensive drug and meet the above blood pressure criteria may be enrolled at the discretion of the investigator
- Participant is generally in good health with the exception of hypertension
- Participant is a nonsmoker and/or has not used nicotine or nicotine-containing products for 6 months
Exclusion
- Participant has a history of any illness that might confound the results of the study or pose and additional risk to the participant if they take part in the study
- Participant has a history of stroke, chronic seizures, or major neurological disorder
- Participant has a disability that can interfere with rising from a semi-recumbent position to the standing position
- Participant has a personal or family history of a bleeding or clotting disorder
- Participant has a history of frequent nosebleeds or recurrent or active gingivitis
- Participant has a history of cancer, except 1) certain skin cancers; 2) cancer successfully treated more than 10 years prior to the study that has not recurred; or, 3) participants who are unlikely to have a recurrence during the study
- Participant has a history of cardiac disease including but not limited to heart valve disease or evidence of secondary cardiac damage
- Participant is categorized as class II or greater according to the New York Heart Association (NYHA) functional classification for heart failure
- Participant is unable to refrain from use of prescription or non-prescription drugs or herbal remedies (such as St. John's Wort) during the study
- Participant anticipates using phosphodiesterase (PDE5) inhibitors \[sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®)\] during the study
- Participant consumes excessive amounts of alcohol (more than 3 drinks per day) or caffeine (more than 6 servings a day)
- Participant has had major surgery, donated or lost 1 unit of blood, or participated in another investigational within 4 weeks prior to the study
- Participant has a history of multiple and/or severe allergies, or has had an anaphylactic reaction or intolerance to any drugs or food
Key Trial Info
Start Date :
August 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01244035
Start Date
August 19 2010
End Date
December 23 2010
Last Update
February 28 2019
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