HypertensionPhase 1NCT01244035

Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Hypertension, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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, and pharmacodynamics of different doses and dose regimens of MK-8266. Only Part I of the study was completed. Read more about this study

Who is it for?: Ages 21 to 60 years, men only
Conditions the study is for: Hypertension
What is being tested?: Treatment A, Treatment B and Treatment C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: No sites listed yet
Study dates: 19 Aug 2010to 23 Dec 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 13Show fewer

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

About this study

Official 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

Conditions: Hypertension
Being tested: Treatment A, Treatment B, Treatment C, Treatment D, Treatment E
Keywords: High blood pressure
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment ADrug
Also called MK-8266 1.3 mg BID
MK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.
Treatment BDrug
Also called MK-8266 0.9 mg FDD
MK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus placebo to match Treatment A on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.
Treatment CDrug
Also called Placebo
Placebo to match MK-8266 Treatments A and B orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.
Treatment DDrug
MK-8266 orally twice daily (1 mg in the morning and 0.4 mg 8 hours later) plus placebo to match Treatment E on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.
Treatment EDrug
MK-8266 0.2 mg orally every 2 hours (total dose of 1.4 mg) plus placebo to match Treatment D on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.
Treatment FDrug
Placebo to match MK-8266 Treatments D and E orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.

Study groups in NCT01244035
Study group	Role	What they receive
Part I - Sequence ABC	Experimental	Treatment A in Period 1, Treatment B in Period 2, and Treatment C in Period 3 Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Part I - Sequence ACB	Experimental	Treatment A in Period 1, Treatment C in Period 2, and Treatment B in Period 3 Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Part I - Sequence BCA	Experimental	Treatment B in Period 1, Treatment C in Period 2, and Treatment A in Period 3 Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Part I - Sequence BAC	Experimental	Treatment B in Period 1, Treatment A in Period 2, and Treatment C in Period 3 Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Part I - Sequence CAB	Experimental	Treatment C in Period 1, Treatment A in Period 2, and Treatment B in Period 3 Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Part I - Sequence CBA	Experimental	Treatment C in Period 1, Treatment B in Period 2, and Treatment A in Period 3 Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Part II - Sequence DEF	Experimental	Treatment D in Period 1, Treatment E in Period 2, and Treatment F in Period 3 Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F
Part II - Sequence DFE	Experimental	Treatment D in Period 1, Treatment F in Period 2, and Treatment E in Period 3 Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F
Part II - Sequence EFD	Experimental	Treatment E in Period 1, Treatment F in Period 2, and Treatment D in Period 3 Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F
Part II - Sequence EDF	Experimental	Treatment E in Period 1, Treatment D in Period 2, and Treatment F in Period 3 Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F
Part II - Sequence FDE	Experimental	Treatment F in Period 1, Treatment D in Period 2, and Treatment E in Period 3 Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F
Part II -Sequence FED	Experimental	Treatment F in Period 1, Treatment E in Period 2, and Treatment D in Period 3 Receives: Drug: Treatment D; Drug: Treatment E; Drug: Treatment F

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events (AEs)
The number of participants with one or more clinical or laboratory AEs was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
Measured: MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3
The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.
Measured: Pre-dose and 0.5, 1, 2, 4, and 8 hours after dosing on Day 1, and pre-dose and 4 and 8 hours after dosing on Day 3 of each period
Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Day 4
The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.
Measured: Predose and 2, 4, and 8 hours after dosing on Day 4 of each period
Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3
The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.
Measured: Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3
Maximum Plasma Concentration (Cmax) of MK-8266 on Day 4
The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.
Measured: Predose and 2, 4, and 8 hours after dosing on Day 4 of each period
Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 1 and Day 3
The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 1 and Day 3.
Measured: Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3
Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 4
The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 4.
Measured: Predose and 2, 4, and 8 hours after dosing on Day 4 of each period
Change From Baseline in Heart Rate (HR)
The effect of MK-8266 and placebo on changes in HR were assessed, as measured by time weighted average change from baseline in HR over 0-24 hours postdose (TWA^0-24 hr) on Day 3. Baseline values for HR are shown in the Baseline Characteristics section.
Measured: Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3
Change From Baseline in Diastolic Blood Pressure (DBP)
The effect of MK-8266 and placebo on changes in diastolic blood pressure (DBP) were assessed, as measured by time weighted average change from baseline in DBP over 0-24 hours postdose (TWA^0-24 hr) on Day 3. Baseline values for DBP are shown in the Baseline Characteristics section.
Measured: Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 201023 Dec 2010

First posted19 Nov 2010 (estimated)
Study start19 Aug 2010
Primary completion23 Dec 2010
Study completion23 Dec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01244035
Sponsor's protocol ID: 8266-008
Other IDs: 2010-021832-32
Status last verified: Oct 2018
First submitted: 17 Nov 2010
Last updated: 28 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01244035
Acronym / sponsor ID: 8266-008
Conditions: Hypertension
Keywords: High blood pressure
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 19 Aug 2010 (actual)
Primary completion: 23 Dec 2010 (actual)
Study completion: 23 Dec 2010 (actual)
First posted: 19 Nov 2010 (estimated)
Results: Posted 28 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 12

Arm	Type	Receives
Part I - Sequence ABC	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatment A in Period 1, Treatment B in Period 2, and Treatment C in Period 3
Part I - Sequence ACB	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatment A in Period 1, Treatment C in Period 2, and Treatment B in Period 3
Part I - Sequence BCA	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatment B in Period 1, Treatment C in Period 2, and Treatment A in Period 3
Part I - Sequence BAC	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatment B in Period 1, Treatment A in Period 2, and Treatment C in Period 3
Part I - Sequence CAB	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatment C in Period 1, Treatment A in Period 2, and Treatment B in Period 3
Part I - Sequence CBA	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CTreatment C in Period 1, Treatment B in Period 2, and Treatment A in Period 3
Part II - Sequence DEF	Experimental	Drug: Treatment D, Drug: Treatment E, Drug: Treatment FTreatment D in Period 1, Treatment E in Period 2, and Treatment F in Period 3
Part II - Sequence DFE	Experimental	Drug: Treatment D, Drug: Treatment E, Drug: Treatment FTreatment D in Period 1, Treatment F in Period 2, and Treatment E in Period 3
Part II - Sequence EFD	Experimental	Drug: Treatment D, Drug: Treatment E, Drug: Treatment FTreatment E in Period 1, Treatment F in Period 2, and Treatment D in Period 3
Part II - Sequence EDF	Experimental	Drug: Treatment D, Drug: Treatment E, Drug: Treatment FTreatment E in Period 1, Treatment D in Period 2, and Treatment F in Period 3
Part II - Sequence FDE	Experimental	Drug: Treatment D, Drug: Treatment E, Drug: Treatment FTreatment F in Period 1, Treatment D in Period 2, and Treatment E in Period 3
Part II -Sequence FED	Experimental	Drug: Treatment D, Drug: Treatment E, Drug: Treatment FTreatment F in Period 1, Treatment E in Period 2, and Treatment D in Period 3

Who may qualify

Ages: 21 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment AAlso: MK-8266 1.3 mg BIDMK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.	Drug	Part I - Sequence ABC, Part I - Sequence ACB, Part I - Sequence BAC, Part I - Sequence BCA, Part I - Sequence CAB, Part I - Sequence CBA
Treatment BAlso: MK-8266 0.9 mg FDDMK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus placebo to match Treatment A on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.	Drug	Part I - Sequence ABC, Part I - Sequence ACB, Part I - Sequence BAC, Part I - Sequence BCA, Part I - Sequence CAB, Part I - Sequence CBA
Treatment CAlso: PlaceboPlacebo to match MK-8266 Treatments A and B orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.	Drug	Part I - Sequence ABC, Part I - Sequence ACB, Part I - Sequence BAC, Part I - Sequence BCA, Part I - Sequence CAB, Part I - Sequence CBA
Treatment DMK-8266 orally twice daily (1 mg in the morning and 0.4 mg 8 hours later) plus placebo to match Treatment E on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.	Drug	Part II - Sequence DEF, Part II - Sequence DFE, Part II - Sequence EDF, Part II - Sequence EFD, Part II - Sequence FDE, Part II -Sequence FED
Treatment EMK-8266 0.2 mg orally every 2 hours (total dose of 1.4 mg) plus placebo to match Treatment D on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.	Drug	Part II - Sequence DEF, Part II - Sequence DFE, Part II - Sequence EDF, Part II - Sequence EFD, Part II - Sequence FDE, Part II -Sequence FED
Treatment FPlacebo to match MK-8266 Treatments D and E orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.	Drug	Part II - Sequence DEF, Part II - Sequence DFE, Part II - Sequence EDF, Part II - Sequence EFD, Part II - Sequence FDE, Part II -Sequence FED

Primary outcome

Adverse Events (AEs)
Time frame: MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo
The number of participants with one or more clinical or laboratory AEs was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3
Time frame: Pre-dose and 0.5, 1, 2, 4, and 8 hours after dosing on Day 1, and pre-dose and 4 and 8 hours after dosing on Day 3 of each period
The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.
Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Day 4
Time frame: Predose and 2, 4, and 8 hours after dosing on Day 4 of each period
The AUC(0-8 hours) of MK-8266 was assessed. The arithmetic mean and standard deviation values of AUC(0-8 hours), based on the raw scale, are provided.
Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3
Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3
The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.
Maximum Plasma Concentration (Cmax) of MK-8266 on Day 4
Time frame: Predose and 2, 4, and 8 hours after dosing on Day 4 of each period
The Cmax of MK-8266 was assessed. The arithmetic mean and standard deviation values of Cmax, based on the raw scale, are provided.
Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 1 and Day 3
Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3
The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 1 and Day 3.
Time to Maximum Plasma Concentration (Tmax) of MK-8266 on Day 4
Time frame: Predose and 2, 4, and 8 hours after dosing on Day 4 of each period
The Tmax of MK-8266 was assessed. Descriptive statistics are provided for the minimum, median and maximum values for the Tmax of MK-8266 on Day 4.
Change From Baseline in Heart Rate (HR)
Time frame: Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3
The effect of MK-8266 and placebo on changes in HR were assessed, as measured by time weighted average change from baseline in HR over 0-24 hours postdose (TWA^0-24 hr) on Day 3. Baseline values for HR are shown in the Baseline Characteristics section.
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Pre-dose (Baseline) and every 30 minutes for the first 4 hours, followed by hourly up to 24 hours after dosing on Day 3
The effect of MK-8266 and placebo on changes in diastolic blood pressure (DBP) were assessed, as measured by time weighted average change from baseline in DBP over 0-24 hours postdose (TWA^0-24 hr) on Day 3. Baseline values for DBP are shown in the Baseline Characteristics section.

Results and safety

Results posted to the registry on 28 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence ABC	5	4
Sequence ACB	5	3
Sequence BCA	6	4
Sequence BAC	5	5
Sequence CAB	5	4
Sequence CBA	5	3

Primary outcome: Adverse Events (AEs)

Time frame: MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo. Count of participants. Unit: Participants

Measure	MK-8266 1.3 mg BID n = 25	MK-8266 0.9 mg FDD n = 26	MK-8266 1 mg QD n = 26	Placebo n = 27
Value	9	16	8	9

Population analysed: All participants who received at least one dose of study treatment

Primary outcome: Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Days 1 and 3

Time frame: Pre-dose and 0.5, 1, 2, 4, and 8 hours after dosing on Day 1, and pre-dose and 4 and 8 hours after dosing on Day 3 of each period. Mean (Standard Deviation). Unit: nM*hr

Measure	MK-8266 1.3 mg BID; MK-8266 1 mg QD n = 24	MK-8266 0.9 mg FDD; MK-8266 1 mg QD n = 24
Day 1	83.4 (22.2)	23.7 (5.96)
Day 3	120 (41.7)	69.3 (25.8)

Population analysed: All participants who received at least one dose of the investigational drug and had assessment of AUC(0-8 hours)

Primary outcome: Area Under the MK-8266 Concentration Versus Time Curve AUC(0-8 Hours) on Day 4

Time frame: Predose and 2, 4, and 8 hours after dosing on Day 4 of each period. Mean (Standard Deviation). Unit: nM*hr

Measure	MK-8266 1.3 mg BID; MK-8266 1 mg QD n = 24	MK-8266 0.9 mg FDD; MK-8266 1 mg QD n = 24
Value	135 (46.6)	139 (43.2)

Population analysed: All participants who received at least one dose of the investigational drug and had assessment of AUC(0-8 hours)

Primary outcome: Maximum Plasma Concentration (Cmax) of MK-8266 on Day 1 and Day 3

Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 14, 15, and 16 hours after dosing on Days 1 and 3. Mean (Standard Deviation). Unit: mg/mL

Measure	MK-8266 1.3 mg BID n = 24	MK-8266 0.9 mg FDD n = 24
Day 1	17.4 (4.01)	8.63 (2.85)
Day 3	20.5 (6.11)	11.0 (3.73)

Population analysed: All participants who received at least one dose of the investigational drug and had assessment for Cmax

Adverse events

Time frame: MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE is reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-8266 1.3 mg BID	0 of 25 (0%)	9 of 25 (36%)	0 of 25
MK-8266 0.9 mg FDD	0 of 26 (0%)	16 of 26 (61.5%)	0 of 26
MK-8266 1 mg QD	0 of 26 (0%)	8 of 26 (30.8%)	0 of 26
Placebo	0 of 27 (0%)	9 of 27 (33.3%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Hypertension, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: MK-8266 1.3 mg BID and 0.9 mg FDD groups: Up to Day 4 in each period; MK-8266 1 mg QD group: the last AE was reported on day 10 after the last dose; Placebo group: Up to 10-14 days after the last dose of placebo). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01244035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.