A Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008 AM1)(COMPLETED)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01244035
• Date of registration: 17/11/2010
• Primary sponsor: Merck
• Public title: A Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008 AM1)(COMPLETED)
• Scientific title: Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics Following Different Dosing Regimens of MK-8266 or Placebo in Subjects With Hypertension
• Date of first enrolment: August 2010
• Target sample size: 31
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01244035
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 21 Years
Age maximum: 60 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Hypertension

Intervention(s)

Drug: Treatment A

Drug: Treatment B

Drug: Treatment C

Drug: Treatment D

Drug: Treatment E

Drug: Treatment F

Primary Outcome(s)

Apparent terminal half-life of MK-8266 (t½) [Time Frame: Four days (Predose Day 1 of each study period through eight hours postdose on Day 4)]

Area under the MK-8266 concentration versus time curve [AUC(0-t)] [Time Frame: Four days (Predose Day 1 of each study period through eight hours postdose on Day 4)]

Maximum plasma concentration of MK-8266 (Cmax) [Time Frame: Four days (Predose Day 1 of each study period through eight hours postdose on Day 4)]

Number of participants with adverse experiences [Time Frame: From day of enrollment to 10-14 days following the last dose of study drug]

Time to maximum plasma concentration of MK-8266 (Tmax) [Time Frame: Four days (Predose Day 1 of each study period through eight hours postdose on Day 4)]

Time-weighted average change from baseline in diastolic blood pressure [Time Frame: Baseline and average over 0-24 hours postdose on Day 3]

Time-weighted average change from baseline in heart rate [Time Frame: Baseline and average over 0-24 hours postdose on Day 3]

Secondary ID(s)

2010-021832-32

MK-8266-008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors