HypertensionPhase 3NCT01307046

MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)

A Phase 3 study testing MK-0954A and Losartan in people with Hypertension, run by Organon and Co.

Completed

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

Trial summary

This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypertension
What is being tested?: MK-0954A and Losartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 336 participants
Where: No sites listed yet
Study dates: 29 Mar 2011to 7 Feb 2012
Phase: Phase 3
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has a diagnosis of essential hypertension.
Participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
Participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
Participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
Participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.

Who cannot join

Regarding hypertension, participant is currently taking > 2 antihypertensive medications.
Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)
Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or a recent history within the last year of drug or alcohol abuse or dependence.
Participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
Participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.

About this study

Official title: A Phase III, Randomized, Active-comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954A in Japanese Patients With Essential Hypertension Uncontrolled With the High Dose of Losartan Potassium

This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.

Conditions: Hypertension
Being tested: MK-0954A, Losartan, Placebo to MK-0954A, Placebo to losartan 100 mg, Placebo to losartan 50 mg
Keywords: Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure
Medical subject headings: Hypertension, Essential Hypertension

What participants receive

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

MK-0954ADrug
Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
LosartanDrug
Tablet containing losartan potassium (100 mg), once daily
Placebo to MK-0954ADrug
Placebo tablet to match MK-0954A, once daily
Placebo to losartan 100 mgDrug
Placebo tablet to match losartan 100 mg, once daily
Placebo to losartan 50 mgDrug
Placebo tablet to match losartan 50 mg, once daily

Study groups in NCT01307046
Study group	Role	What they receive
MK-0954A	Experimental	Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks. Receives: Drug: MK-0954A; Drug: Placebo to losartan 100 mg; Drug: Placebo to losartan 50 mg
Losartan	Active comparator	Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks. Receives: Drug: Losartan; Drug: Placebo to MK-0954A; Drug: Placebo to losartan 50 mg

What is being measured

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

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)
Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).
Measured: Baseline and Week 8
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Measured: 8 weeks

Secondary outcomes (1)

Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)
Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).
Measured: Baseline and Week 8

Timeline

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

29 Mar 20117 Feb 2012

First posted2 Mar 2011 (estimated)
Study start29 Mar 2011
Primary completion7 Feb 2012
Study completion7 Feb 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 336 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01307046
Sponsor's protocol ID: 0954A-352
Status last verified: Feb 2022
First submitted: 1 Mar 2011
Last updated: 17 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Fujimoto G, Azuma K, Shirakawa M, Hanson ME, Fujita KP. Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials. Hypertens Res. 2014 Dec;37(12):1042-9. doi: 10.1038/hr.2014.114. Epub 2014 Jul 3.
PubMed 24990091

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 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Active-comparator Controlled Clinical Trial to Study the Efficacy and Safety of MK-0954A in Japanese Patients With Essential Hypertension Uncontrolled With the High Dose of Losartan Potassium
ClinicalTrials.gov ID: NCT01307046
Acronym / sponsor ID: 0954A-352
Conditions: Hypertension
Keywords: Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 336 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 29 Mar 2011 (actual)
Primary completion: 7 Feb 2012 (actual)
Study completion: 7 Feb 2012 (actual)
First posted: 2 Mar 2011 (estimated)
Results: Posted 22 Mar 2013

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 conducted to evaluate the efficacy of MK-0954A in essential hypertension participants who are not adequately controlled with losartan.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MK-0954A	Experimental	Drug: MK-0954A, Drug: Placebo to losartan 100 mg, Drug: Placebo to losartan 50 mgParticipants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
Losartan	Active comparator	Drug: Losartan, Drug: Placebo to MK-0954A, Drug: Placebo to losartan 50 mgParticipants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participant has a diagnosis of essential hypertension.
Participant is not treated with antihypertensive medication and meets protocol-specified blood pressure criteria.
Participant is treated with single antihypertensive medication, and meets protocol-specified blood pressure criteria.
Participant is being treated with up to dual oral antihypertensive medications, and will be able to discontinue the prior antihypertensive medication.
Participant has no clinically meaningful findings to be disqualified from the study at the discretion of the investigator.

Key exclusion criteria (5 listed)

Regarding hypertension, participant is currently taking > 2 antihypertensive medications.
Participant has a history of significant multiple and/or severe allergies to ingredients of Nu-lotan or Preminent and thiazide drug or related drug (i.e., sulfonamide-containing "chlortalidone" medicines)
Participant is, at the time of signing informed consent, a user of recreational or illicit drugs or a recent history within the last year of drug or alcohol abuse or dependence.
Participant is pregnant or breastfeeding or expecting to conceive or has a positive pregnancy test at the screening visit.
Participant is currently participating or has participated in a study with an investigational compound (except losartan at any doses) or device within 30 days of signing informed consent.

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-0954ATablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily	Drug	MK-0954A
LosartanTablet containing losartan potassium (100 mg), once daily	Drug	Losartan
Placebo to MK-0954APlacebo tablet to match MK-0954A, once daily	Drug	Losartan
Placebo to losartan 100 mgPlacebo tablet to match losartan 100 mg, once daily	Drug	MK-0954A
Placebo to losartan 50 mgPlacebo tablet to match losartan 50 mg, once daily	Drug	Losartan, MK-0954A

Primary outcome

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)
Time frame: Baseline and Week 8
Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration (Day 56 ± 7 days).
Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Time frame: 8 weeks

1 secondary outcome

Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP)
Time frame: Baseline and Week 8

Results and safety

Results posted to the registry on 22 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-0954A	166	154
Losartan	170	159

Primary outcome: Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP)

Time frame: Baseline and Week 8. Least squares mean (95% Confidence Interval). Unit: mmHg

Measure	MK-0954A n = 166	Losartan n = 170
Value	-8.7 (0.6)	-3.6 (0.6)

MK-0954A vs Losartan: Difference in least square means: -5.1 (95% CI -6.8 to -3.4), p <.001, constrained longitudinal data analysis

Population analysed: Full Analysis Set (FAS) population: defined as all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that required baseline data

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

Time frame: 8 weeks. Number. Unit: percentage of participants

Measure	MK-0954A n = 166	Losartan n = 170
Value	31.3	26.5

Population analysed: All-Patients-as-Treated (APaT) Population: defined as all randomized participants who received at least one dose of study treatment.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0954A	0 of 166 (0%)	9 of 166 (5.4%)	Not reported
Losartan	0 of 170 (0%)	9 of 170 (5.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24990091Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Fujimoto G, Azuma K, Shirakawa M, Hanson ME, Fujita KP. Efficacy and safety of losartan 100 mg/hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension: two randomized, controlled trials. Hypertens Res. 2014 Dec;37(12):1042-9. doi: 10.1038/hr.2014.114. Epub 2014 Jul 3.
Individual participant dataSharing planned: No

Related trials for Hypertension

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-0954A and Losartan in people with Hypertension, run by Organon and Co.

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 5 inclusion and 5 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 17 May 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 22 Mar 2013). 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 Trough Sitting Diastolic Blood Pressure (SiDBP) (time frame: Baseline and Week 8). 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 NCT01307046, which also lists 1 linked publication.

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 17 May 2024.