HypertensionPhase 1NCT01025843

Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)

A Phase 1 study testing MK-5478, Comparator: Candesartan cilexetil and Comparator: Pbo 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 is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: MK-5478, Comparator: Candesartan cilexetil and Comparator: Pbo
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: No sites listed yet
Study dates: 1 Dec 2009to 1 May 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 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Part I:
Is a male between 18 to 50 years of age
Is in good health
Is a non-smoker
Part II:
Is male of non-child bearing potential between 18 and 50 years of age
Has hypertension (high blood pressure)

Who cannot join

Part I and Part II:
Has a history of stroke, seizures or major neurological disorder
Has a history of cancer
Has a history of any cardiovascular disease
Is unable to refrain from the use of any prescription or non-prescription drugs
Consumes excessive amounts of alcohol or caffeine
Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

About this study

Official title: A Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension

Conditions: Hypertension
Being tested: MK-5478, Comparator: Candesartan cilexetil, Comparator: Pbo
Medical subject headings: Hypertension

What participants receive

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

MK-5478Drug
In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.
Comparator: Candesartan cilexetilDrug
Also called Atacand/Amias
Single dose administration of candesartan, 32 mg oral tablet
Comparator: PboDrug
Placebo

Study groups in NCT01025843
Study group	Role	What they receive
Pbo → 5 mg → Candesartan → 24 mg → 38 mg	Experimental	Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
1 mg → 5 mg → 12 mg → Candesartan → Pbo	Experimental	1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
1 mg → Candesartan → Pbo → 24 mg → 38 mg	Experimental	1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
1 mg → 5 mg → 12 mg → Pbo → Candesartan	Experimental	1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan	Experimental	Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
2 mg→Pbo → Candesartan → Pbo fed→38 mg	Experimental	2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
2 mg→Candesartan→Pbo→Candesartan fed→38 mg	Experimental	2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
2 mg → 8 mg → 18 mg → 2 mg fed → Pbo	Experimental	2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
Candesartan→8 mg→ 18 mg →2 mg fed→38 mg	Experimental	Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo
Candesartan→Pbo → 12 mg → 24 mg→38 mg	Experimental	Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods. Receives: Drug: MK-5478; Drug: Comparator: Candesartan cilexetil; Drug: Comparator: Pbo

What is being measured

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

Number of Participants With One or More Adverse Events (AEs)
An AE is 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. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Measured: Up to 14 days after administration of last dose of study drug (up to Day 52)
Number of Participants Who Discontinued Treatment Due to an AE
An AE is 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. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Measured: Up to 24 hours after administration of study drug

Secondary outcomes (3)

Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan
Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure AUC 0-infinity of MK-5478 and Candesartan
Measured: Pre-dose and up to 48 hours postdose
Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan
Central blood pressure (CBP) parameters will be measured and used to derive the aortic augmentation index (AIx). The AIx quantifies the contribution of back-reflected outgoing systolic pressure waves to late-systolic central blood pressure, which increases with decreasing aortic compliance. AIx is measured by pulse wave analysis using the SphygmoCor System supplied by AtCor Medical. Results with a > 5% decrease in AIx were planned for analysis; results with a < 5% decrease in AIx were not analysed.
Measured: Baseline and 1 to 3 hours postdose
Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan
Blood was collected at the following time points: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 36, and 48 hours post-dose in order to measure the Cmax of MK-5478 and Candesartan
Measured: Pre-dose and up to 48 hours postdose

Timeline

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

1 Dec 20091 May 2010

First posted4 Dec 2009 (estimated)
Study start1 Dec 2009
Primary completion1 May 2010
Study completion1 May 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01025843
Sponsor's protocol ID: 5478-001
Other IDs: 2009-016048-38, 2009
Status last verified: Aug 2018
First submitted: 2 Dec 2009
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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All Hypertension trials

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 Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension
ClinicalTrials.gov ID: NCT01025843
Acronym / sponsor ID: 5478-001
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Dec 2009 (actual)
Primary completion: 1 May 2010 (actual)
Study completion: 1 May 2010 (actual)
First posted: 4 Dec 2009 (estimated)
Results: Posted 26 Feb 2016

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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 10

Arm	Type	Receives
Pbo → 5 mg → Candesartan → 24 mg → 38 mg	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: PboPlacebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
1 mg → 5 mg → 12 mg → Candesartan → Pbo	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: Pbo1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
1 mg → Candesartan → Pbo → 24 mg → 38 mg	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: Pbo1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
1 mg → 5 mg → 12 mg → Pbo → Candesartan	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: Pbo1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: PboPlacebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
2 mg→Pbo → Candesartan → Pbo fed→38 mg	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: Pbo2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
2 mg→Candesartan→Pbo→Candesartan fed→38 mg	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: Pbo2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
2 mg → 8 mg → 18 mg → 2 mg fed → Pbo	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: Pbo2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
Candesartan→8 mg→ 18 mg →2 mg fed→38 mg	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: PboCandesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
Candesartan→Pbo → 12 mg → 24 mg→38 mg	Experimental	Drug: MK-5478, Drug: Comparator: Candesartan cilexetil, Drug: Comparator: PboCandesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Is a male between 18 to 50 years of age
Is in good health
Is a non-smoker
Is male of non-child bearing potential between 18 and 50 years of age
Has hypertension (high blood pressure)

Key exclusion criteria (7 listed)

Has a history of stroke, seizures or major neurological disorder
Has a history of cancer
Has a history of any cardiovascular disease
Is unable to refrain from the use of any prescription or non-prescription drugs
Consumes excessive amounts of alcohol or caffeine

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-5478In Part I: Single dose administration of MK-5478 oral capsules, total doses of 1, 2, 5, 8, 12, 18, 24 or 38 mg.	Drug	1 mg → 5 mg → 12 mg → Candesartan → Pbo, 1 mg → 5 mg → 12 mg → Pbo → Candesartan, 1 mg → Candesartan → Pbo → 24 mg → 38 mg, 2 mg → 8 mg → 18 mg → 2 mg fed → Pbo, 2 mg→Candesartan→Pbo→Candesartan fed→38 mg, 2 mg→Pbo → Candesartan → Pbo fed→38 mg, Candesartan→8 mg→ 18 mg →2 mg fed→38 mg, Candesartan→Pbo → 12 mg → 24 mg→38 mg, Pbo → 5 mg → Candesartan → 24 mg → 38 mg, Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan
Comparator: Candesartan cilexetilAlso: Atacand/AmiasSingle dose administration of candesartan, 32 mg oral tablet	Drug	1 mg → 5 mg → 12 mg → Candesartan → Pbo, 1 mg → 5 mg → 12 mg → Pbo → Candesartan, 1 mg → Candesartan → Pbo → 24 mg → 38 mg, 2 mg → 8 mg → 18 mg → 2 mg fed → Pbo, 2 mg→Candesartan→Pbo→Candesartan fed→38 mg, 2 mg→Pbo → Candesartan → Pbo fed→38 mg, Candesartan→8 mg→ 18 mg →2 mg fed→38 mg, Candesartan→Pbo → 12 mg → 24 mg→38 mg, Pbo → 5 mg → Candesartan → 24 mg → 38 mg, Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan
Comparator: PboPlacebo	Drug	1 mg → 5 mg → 12 mg → Candesartan → Pbo, 1 mg → 5 mg → 12 mg → Pbo → Candesartan, 1 mg → Candesartan → Pbo → 24 mg → 38 mg, 2 mg → 8 mg → 18 mg → 2 mg fed → Pbo, 2 mg→Candesartan→Pbo→Candesartan fed→38 mg, 2 mg→Pbo → Candesartan → Pbo fed→38 mg, Candesartan→8 mg→ 18 mg →2 mg fed→38 mg, Candesartan→Pbo → 12 mg → 24 mg→38 mg, Pbo → 5 mg → Candesartan → 24 mg → 38 mg, Pbo→ 8 mg→ 18 mg → 2 mg fed→Candesartan

Primary outcome

Number of Participants With One or More Adverse Events (AEs)
Time frame: Up to 14 days after administration of last dose of study drug (up to Day 52)
An AE is 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. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Number of Participants Who Discontinued Treatment Due to an AE
Time frame: Up to 24 hours after administration of study drug
An AE is 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. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.

3 secondary outcomes

Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan
Time frame: Pre-dose and up to 48 hours postdose
Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan
Time frame: Baseline and 1 to 3 hours postdose
Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan
Time frame: Pre-dose and up to 48 hours postdose

Results and safety

Results posted to the registry on 26 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pbo → 5 mg → Candesartan → 24 mg → 38 mg	2	2
1 mg → 5 mg → 12 mg → Candesartan → Pbo	2	2
1 mg → Candesartan → Pbo → 24 mg → 38 mg	2	2
1 mg → 5 mg → 12 mg → Pbo → Candesartan	2	2
Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan	2	2
2 mg→Pbo → Candesartan → Pbo Fed → 38 mg	2	2
2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg	2	2
2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo	2	2
Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg	2	2
Candesartan → Pbo → 12 mg → 24 mg → 38 mg	2	2

Primary outcome: Number of Participants With One or More Adverse Events (AEs)

Time frame: Up to 14 days after administration of last dose of study drug (up to Day 52). Number. Unit: Participants

Measure	MK-5478 1 mg n = 6	MK-5478 2 mg n = 6	MK-5478 5 mg n = 6	MK-5478 8 mg n = 6	MK-5478 12 mg n = 6	MK-5478 18 mg n = 6	MK-5478 24 mg n = 6	MK-5478 38 mg n = 5	MK-5478 2 mg - Fed n = 6	Candesartan 32 mg n = 15	Candesartan 32 mg - Fed n = 2	Candesartan Placebo n = 2	MK-5478 Placebo n = 16
Value	5	3	3	4	4	3	2	2	1	9	0	1	6

Population analysed: All participants who received at least one dose of the investigational drug, according to the treatment(s) they actually received; according to study drug taken at time of the event and not by randomly assigned sequence.

Primary outcome: Number of Participants Who Discontinued Treatment Due to an AE

Time frame: Up to 24 hours after administration of study drug. Number. Unit: Participants

Measure	MK-5478 1 mg n = 6	MK-5478 2 mg n = 6	MK-5478 5 mg n = 6	MK-5478 8 mg n = 6	MK-5478 12 mg n = 6	MK-5478 18 mg n = 6	MK-5478 24 mg n = 6	MK-5478 38 mg n = 5	MK-5478 2 mg - Fed n = 6	Candesartan 32 mg n = 15	Candesartan 32 mg - Fed n = 2	Candesartan Placebo n = 2	MK-5478 Placebo n = 16
Value	0	0	0	0	0	0	0	0	0	0	0	0	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 days after administration of last dose of study drug (up to Day 52). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-5478 1 mg	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
MK-5478 2 mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
MK-5478 5 mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
MK-5478 8 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
MK-5478 12 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
MK-5478 18 mg	0 of 6 (0%)	3 of 6 (50%)	Not reported
MK-5478 24 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
MK-5478 38 mg	0 of 5 (0%)	2 of 5 (40%)	Not reported
MK-5478 2 mg - Fed	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
MK-5478 Placebo	0 of 16 (0%)	6 of 16 (37.5%)	Not reported
Candesartan 32 mg	0 of 15 (0%)	9 of 15 (60%)	Not reported
Candesartan 32 mg - Fed	0 of 2 (0%)	0 of 2 (0%)	Not reported
Candesartan Placebo	0 of 2 (0%)	1 of 2 (50%)	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-5478, Comparator: Candesartan cilexetil and Comparator: Pbo 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 7 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. 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 26 Feb 2016). 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?

Number of Participants With One or More Adverse Events (AEs) (time frame: Up to 14 days after administration of last dose of study drug (up to Day 52)). The study lists 2 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 NCT01025843.

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.