HypertensionPhase 1NCT01370655

A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009)

A Phase 1 study testing MK-7145 and Hydrochlorothiazide (HCTZ) 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

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Trial summary

This study is being done to evaluate the antihypertensive efficacy and tolerability of MK-7145 in participants with mild-to-moderate hypertension. The primary hypotheses for the study were as follows: 1. Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Hypertension
What is being tested?: MK-7145 and Hydrochlorothiazide (HCTZ)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: No sites listed yet
Study dates: 15 Jun 2011to 26 Jan 2012
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 18 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of essential hypertension
Body mass index (BMI) ≤35 kg/m^2
Participant in general good health
No history of clinically significant arrhythmias or clinically significant abnormality on electrocardiogram (ECG)
No history of clinically significant cardiac disease
Treatment-naïve or taking up to 2 antihypertensive therapeutic agents
Non-smoker and/or has not used nicotine or nicotine-containing products for at least 6 months

Who cannot join

Participant has low plasma potassium
History of stroke, chronic seizures, or major neurological disorder
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of osteoporosis
Active or history of nephrocalcinosis, nephrolithiasis or hypercalciuria
Orthostatic change in vital sign measurements while going from a semi-recumbent to standing position accompanied by symptoms

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Functional disability that can interfere with rising from a semi-recumbent position to the standing position
History of malignant neoplastic disease. Exceptions: (1) adequately treated non-melanomatous skin carcinoma; (2) other malignancies which have been successfully treated >10 years prior to the prestudy (screening) visit, (3) unlikely to sustain a recurrence
Participant is unable to refrain from the use of prescription and non-prescription drugs such as high-dose aspirin (≥325 mg/day), strong/moderate Cytochrome P450 3A4 (CYP3A4) inhibitors (such as ritonavir, indinavir, nelfinavir, erythromycin, telithromycin, clarithromycin, chloramphenicol, fluconazole, ketoconazole, itraconazole, nefazodone, aprepitant, verapamil, or diltiazem) as well as strong/moderate CYP3A4 inducers (such as phenytoin, carbamazepine, oxcarbazepine, phenobarbital, efavirenz, nevirapine, etravirine, rifampicin, modafinil, St Johns Wort, cyproterone, or progestin) beginning approximately 2 weeks (or 5 half-lives), prior to administration of the initial dose of study drug until the post study visit
Current use of non-steroidal anti-inflammatory drugs (NSAIDs) other than low dose aspirin, aluminum- or magnesium-containing antacids, sucralfate, metal cations such as iron, multivitamins containing iron or zinc that cannot be discontinued at least 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug until the post study visit
Consumption of excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
Participant consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Major surgery, donation or lost 1 unit of blood (approximately 500 mL), or participation in another investigational study within 4 weeks prior to the prestudy (screening)
History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Regular use of any illicit drugs or history of drug abuse within approximately 6 months
Dehydration or volume-depletion

About this study

Official title: A Phase Ib, Randomized, Double-Blind, 4-Treatment, 2-Period Incomplete Block Study to Evaluate the Multiple Dose Effects of MK-7145 and Hydrochlorothiazide Compared to Placebo on Blood Pressure in Male Patients With Hypertension

This study is being done to evaluate the antihypertensive efficacy and tolerability of MK-7145 in participants with mild-to-moderate hypertension.

The primary hypotheses for the study were as follows:

Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood pressure (SBP) in male participants with mild to moderate hypertension that is superior to placebo, as measured by time weighted average change from baseline over 24 hours postdose (TWA0-24hrs) on dosing Day 28
Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male participants with mild to moderate hypertension that is similar to hydrochlorothiazide (HCTZ), as measured by TWA0-24hrs on dosing Day 28
The effect of MK-7145 and HCTZ on natriuresis (UNaV) as well as SBP and diastolic blood pressure (DBP), both as measured by TWA0-24hrs, will be estimated
Multiple dose administration of MK-7145 for 4 weeks will be generally safe and well-tolerated.

Conditions: Hypertension
Being tested: MK-7145, Hydrochlorothiazide (HCTZ), Placebo to MK-7145, Placebo to HCTZ
Medical subject headings: Hypertension

What participants receive

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

MK-7145Drug
Hydrochlorothiazide (HCTZ)Drug
Placebo to MK-7145Drug
Placebo to HCTZDrug

Study groups in NCT01370655
Study group	Role	What they receive
MK-7145 6 mg (Treatment A)	Experimental	MK-7145 3 mg (three x 1-mg MK-7145 capsules administered orally) and placebo to HCTZ (two 12.5-mg capsules) then three x 1-mg MK-7145 capsules 4 hours later, daily for 4 weeks. Receives: Drug: MK-7145; Drug: Placebo to HCTZ
MK-7145 3 mg (Treatment B)	Experimental	MK-7145 3 mg (one 2mg MK-7145 and one MK-7145 placebo capsule) then one 1-mg MK-7145 capsule and two MK-7145 placebo capsules 4 hours later and placebo to HCTZ (2 capsules once daily) daily for 4 weeks. Receives: Drug: MK-7145; Drug: Placebo to MK-7145; Drug: Placebo to HCTZ
Hydrochlorothiazide 25 mg (Treatment C)	Active comparator	HCTZ 25 mg (two 12.5-mg capsules) and placebo to MK-7145 (one 3-mg capsule) then placebo for MK-7145 (one 3-mg capsule) 4 hours later daily for 4 weeks. Receives: Drug: Hydrochlorothiazide (HCTZ); Drug: Placebo to MK-7145
Placebo (Treatment D)	Placebo comparator	Placebo to MK-7145 (2 x 3-mg capsules) and placebo to HCTZ 25 mg (2 capsules) then placebo to MK-7145 (2 x 3-mg capsules) 4 hours later daily for 4 weeks Receives: Drug: Placebo to MK-7145; Drug: Placebo to HCTZ

What is being measured

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

Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)
Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.
Measured: Baseline and Day 28
Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)
Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.
Measured: Baseline and Day 28
Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1
Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.
Measured: Baseline (Day-1) and Day 1
Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.
Measured: Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)
Percentage of Participants Who Had Study Discontinued During the Study Due to an Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had the administration of the study drug discontinued during the study was summarized by study drug taken at the time of the AE. Participants may or may not have completed the study.
Measured: up to 4 weeks of each treatment period
Percentage of Participants Who Experienced at Least 1 Drug-related Adverse Event (AE)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE that was reported as at least possibly-related to the study was summarized by study drug taken at the time of the AE.
Measured: Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)

Secondary outcomes (1)

Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28
Urine potassium (K+) levels were measured over 24-hours on Day -1 and on Day 28. The total amount of K+ excreted in the urine for Day-1 (baseline) and Day 28 were calculated and the difference between the 2 values was recorded.
Measured: Baseline (Day -1) and Day 28

Timeline

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

15 Jun 201126 Jan 2012

First posted10 Jun 2011 (estimated)
Study start15 Jun 2011
Primary completion19 Dec 2011
Study completion26 Jan 2012

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: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01370655
Sponsor's protocol ID: 7145-009
Status last verified: Aug 2018
First submitted: 8 Jun 2011
Last updated: 21 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.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

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib, Randomized, Double-Blind, 4-Treatment, 2-Period Incomplete Block Study to Evaluate the Multiple Dose Effects of MK-7145 and Hydrochlorothiazide Compared to Placebo on Blood Pressure in Male Patients With Hypertension
ClinicalTrials.gov ID: NCT01370655
Acronym / sponsor ID: 7145-009
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 15 Jun 2011 (actual)
Primary completion: 19 Dec 2011 (actual)
Study completion: 26 Jan 2012 (actual)
First posted: 10 Jun 2011 (estimated)
Results: Posted 4 Apr 2017

Clinical summary

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

This study is being done to evaluate the antihypertensive efficacy and tolerability of MK-7145 in participants with mild-to-moderate hypertension.

The primary hypotheses for the study were as follows:

Multiple dose administration of 6-mg MK-7145 results in a reduction in systolic blood pressure (SBP) in male participants with mild to moderate hypertension that is superior to placebo, as measured by time weighted average change from baseline over 24 hours postdose (TWA0-24hrs) on dosing Day 28
Multiple dose administration of 6-mg MK-7145 results in a reduction in SBP in male participants with mild to moderate hypertension that is similar to hydrochlorothiazide (HCTZ), as measured by TWA0-24hrs on dosing Day 28
The effect of MK-7145 and HCTZ on natriuresis (UNaV) as well as SBP and diastolic blood pressure (DBP), both as measured by TWA0-24hrs, will be estimated
Multiple dose administration of MK-7145 for 4 weeks will be generally safe and well-tolerated.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
MK-7145 6 mg (Treatment A)	Experimental	Drug: MK-7145, Drug: Placebo to HCTZMK-7145 3 mg (three x 1-mg MK-7145 capsules administered orally) and placebo to HCTZ (two 12.5-mg capsules) then three x 1-mg MK-7145 capsules 4 hours later, daily for 4 weeks.
MK-7145 3 mg (Treatment B)	Experimental	Drug: MK-7145, Drug: Placebo to MK-7145, Drug: Placebo to HCTZMK-7145 3 mg (one 2mg MK-7145 and one MK-7145 placebo capsule) then one 1-mg MK-7145 capsule and two MK-7145 placebo capsules 4 hours later and placebo to HCTZ (2 capsules once daily) daily for 4 weeks.
Hydrochlorothiazide 25 mg (Treatment C)	Active comparator	Drug: Hydrochlorothiazide (HCTZ), Drug: Placebo to MK-7145HCTZ 25 mg (two 12.5-mg capsules) and placebo to MK-7145 (one 3-mg capsule) then placebo for MK-7145 (one 3-mg capsule) 4 hours later daily for 4 weeks.
Placebo (Treatment D)	Placebo comparator	Drug: Placebo to MK-7145, Drug: Placebo to HCTZPlacebo to MK-7145 (2 x 3-mg capsules) and placebo to HCTZ 25 mg (2 capsules) then placebo to MK-7145 (2 x 3-mg capsules) 4 hours later daily for 4 weeks

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of essential hypertension
Body mass index (BMI) ≤35 kg/m^2
Participant in general good health
No history of clinically significant arrhythmias or clinically significant abnormality on electrocardiogram (ECG)
No history of clinically significant cardiac disease

Key exclusion criteria (16 listed)

Participant has low plasma potassium
History of stroke, chronic seizures, or major neurological disorder
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
History of osteoporosis
Active or history of nephrocalcinosis, nephrolithiasis or hypercalciuria

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
MK-7145	Drug	MK-7145 3 mg (Treatment B), MK-7145 6 mg (Treatment A)
Hydrochlorothiazide (HCTZ)	Drug	Hydrochlorothiazide 25 mg (Treatment C)
Placebo to MK-7145	Drug	Hydrochlorothiazide 25 mg (Treatment C), MK-7145 3 mg (Treatment B), Placebo (Treatment D)
Placebo to HCTZ	Drug	MK-7145 3 mg (Treatment B), MK-7145 6 mg (Treatment A), Placebo (Treatment D)

Primary outcome

Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)
Time frame: Baseline and Day 28
Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.
Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)
Time frame: Baseline and Day 28
Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.
Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1
Time frame: Baseline (Day-1) and Day 1
Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.
Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)
Time frame: Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.
Percentage of Participants Who Had Study Discontinued During the Study Due to an Adverse Event (AE)
Time frame: up to 4 weeks of each treatment period
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had the administration of the study drug discontinued during the study was summarized by study drug taken at the time of the AE. Participants may or may not have completed the study.
Percentage of Participants Who Experienced at Least 1 Drug-related Adverse Event (AE)
Time frame: Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE that was reported as at least possibly-related to the study was summarized by study drug taken at the time of the AE.

1 secondary outcome

Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28
Time frame: Baseline (Day -1) and Day 28

Results and safety

Results posted to the registry on 4 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A → Treatment C	7	5
Treatment C → Treatment A	7	7
Treatment A → Treatment D	3	3
Treatment D → Treatment A	3	3
Treament D → Treatment C	3	3
Treatment C → Treatment D	4	4
Treatment A → Treatment B	4	3
Treatment B → Treatment A	4	4
Treatment B → Treatment C	3	3
Treatment C → Treatment B	2	2
Treatment B → Treatment D	3	3
Treatment D → Treament B	3	3

Primary outcome: Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)

Time frame: Baseline and Day 28. Least squares mean (90% Confidence Interval). Unit: mmHg

Measure	MK-7145 3 mg n = 17	MK-7145 6 mg n = 25	HCTZ 25 mg n = 21	Placebo n = 16
Value	-9.5 (-12.7 to -6.4)	-10.2 (-12.8 to -7.6)	-4.8 (-7.6 to -1.9)	-2.8 (-6.1 to 0.4)

MK-7145 6 mg vs Placebo: Difference in Least square (LS) means: -7.4 (80% CI -10.6 to -4.1)
MK-7145 6 mg vs HCTZ 25 mg: Difference in LS means: -5.4 (90% CI -9.2 to -1.6)
MK-7145 3 mg vs HCTZ 25 mg: Difference in LS means: -4.8 (90% CI -9.0 to -0.5)

Population analysed: All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.

Primary outcome: Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)

Time frame: Baseline and Day 28. Least squares mean (90% Confidence Interval). Unit: mmHg

Measure	MK-7145 3 mg n = 17	MK-7145 6 mg n = 25	HCTZ 25 mg n = 21	Placebo n = 16
Value	-4.5 (-6.7 to -2.3)	-4.3 (-6.2 to -2.5)	-1.5 (-3.5 to 0.6)	-1.1 (-3.4 to 1.2)

MK-7145 6 mg vs Placebo: Difference in LS means: -3.2 (90% CI -6.1 to -0.3)
MK-7145 6 mg vs HCTZ 25 mg: Difference in LS means: -2.9 (90% CI -5.5 to -0.2)
MK-7145 3 mg vs HCTZ 25 mg: Difference in LS means: -3.0 (90% CI -6.0 to -0.1)

Primary outcome: Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1

Time frame: Baseline (Day-1) and Day 1. Least squares mean (90% Confidence Interval). Unit: mmol/day

Measure	MK-7145 3 mg n = 17	MK-7145 6 mg n = 25	HCTZ 25 mg n = 21	Placebo n = 16
Value	0.4 (-31.0 to 31.7)	46.0 (20.3 to 71.7)	64.1 (36.6 to 91.6)	-30.5 (-61.0 to -0.1)

MK-7145 6 mg vs Placebo: Difference in LS means: 76.5 (80% CI 49.2 to 103.8)
MK-7145 3 mg vs HCTZ 25 mg: Difference in LS means: -63.7 (90% CI -100.8 to -26.7)
MK-7145 6 mg vs HCTZ 25 mg: Difference in LS means: -18.1 (90% CI -49.1 to 12.9)

Primary outcome: Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)

Time frame: Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period). Number. Unit: Percentage of Participants

Measure	MK-7145 3 mg n = 19	MK-7145 6 mg n = 28	HCTZ 25 mg n = 26	Placebo n = 19
Value	84.2	78.6	73.1	47.4

Population analysed: All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 14 days post last dose of study drug for each treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-7145 3 mg	0 of 19 (0%)	16 of 19 (84.2%)	Not reported
MK-7145 6 mg	1 of 28 (3.6%)	19 of 28 (67.9%)	Not reported
HCTZ 25 mg	2 of 26 (7.7%)	15 of 26 (57.7%)	Not reported
Placebo	0 of 19 (0%)	9 of 19 (47.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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 MK-7145 and Hydrochlorothiazide (HCTZ) 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 7 inclusion and 16 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 21 Sep 2018. 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. Some participants in this study may receive a placebo. 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 4 Apr 2017). 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?

Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP) (time frame: Baseline and Day 28). The study lists 6 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 NCT01370655.

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 21 Sep 2018.