HypertensionPhase 3NCT01307033

A Long-term Study of the Safety of MK-0954A in Patients With Essential Hypertension (MK-0954A-351)

A Phase 3 study testing MK-0954A and MK-954H 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 safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg). 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 MK-954H
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 278 participants
Where: No sites listed yet
Study dates: 29 Mar 2011to 4 Dec 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 being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
Participant has a mean trough SiDBP of >=90mmHg and < 110mmHg.
Participant has a mean trough SiSBP of >=140mmHg and < 200mmHg.
Participant has no clinically significant abnormality at screening visit.

Who cannot join

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 has had a recent history within the last year of drug or alcohol abuse or dependence.
Participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit.
Participant is currently participating or has participated in a study with an investigational compound or device within 30 days of signing informed consent.

About this study

Official title: A Phase III, Randomized, Active-comparator Controlled and a Long-term Clinical Trial to Study the Safety of MK-0954A (L100/H12.5 mg) in Japanese Patients With Essential Hypertension Uncontrolled With MK-954H (L50/H12.5 mg) [PREMINENT®]

This study is being conducted to evaluate the safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

Conditions: Hypertension
Being tested: MK-0954A, MK-954H, Placebo to MK-0954A, Placebo to MK-954H
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
MK-954HDrug
Also called Preminent®
Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily
Placebo to MK-0954ADrug
Placebo tablet to match MK-0954A, once daily
Placebo to MK-954HDrug
Placebo tablet to match MK-954H, once daily

Study groups in NCT01307033
Study group	Role	What they receive
MK-954H (L50/H12.5)	Active comparator	One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension) Receives: Drug: MK-954H; Drug: Placebo to MK-0954A
MK-0954A (L100/H12.5)	Experimental	One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension Receives: Drug: MK-0954A; Drug: Placebo to MK-954H

What is being measured

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

Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)
Measured: Up to 52 weeks

Secondary outcomes (2)

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.
Measured: Baseline and Week 8 (End of Double-blind Period)
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Blood pressure (BP) was measured with an automatic sphygmomanometer after participant has been resting in a sitting position for at least 10 minutes. BP was determined averaging 3 replicate measurements obtained at least a 1- to 2-minute interval between BP measurements. The recorded BP was the calculated average of the 3 readings.
Measured: Baseline and Week 8 (End of Double-blind Period)

Timeline

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

29 Mar 20114 Dec 2012

First posted2 Mar 2011 (estimated)
Study start29 Mar 2011
Primary completion4 Dec 2012
Study completion4 Dec 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: 278 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01307033
Sponsor's protocol ID: 0954A-351
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

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 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 and a Long-term Clinical Trial to Study the Safety of MK-0954A (L100/H12.5 mg) in Japanese Patients With Essential Hypertension Uncontrolled With MK-954H (L50/H12.5 mg) [PREMINENT®]
ClinicalTrials.gov ID: NCT01307033
Acronym / sponsor ID: 0954A-351
Conditions: Hypertension
Keywords: Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 278 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 29 Mar 2011 (actual)
Primary completion: 4 Dec 2012 (actual)
Study completion: 4 Dec 2012 (actual)
First posted: 2 Mar 2011 (estimated)
Results: Posted 6 Jan 2014

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 safety of MK-0954A (L100/H12.5 mg) in essential hypertension participants who are uncontrolled with MK-954H (L50/H12.5 mg).

Study design

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

Arm	Type	Receives
MK-954H (L50/H12.5)	Active comparator	Drug: MK-954H, Drug: Placebo to MK-0954AOne combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
MK-0954A (L100/H12.5)	Experimental	Drug: MK-0954A, Drug: Placebo to MK-954HOne combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension

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 being treated with a single, or dual combination treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
Participant has a mean trough SiDBP of >=90mmHg and < 110mmHg.
Participant has a mean trough SiSBP of >=140mmHg and < 200mmHg.
Participant has no clinically significant abnormality at screening visit.

Key exclusion criteria (5 listed)

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 has had a recent history within the last year of drug or alcohol abuse or dependence.
Participant is pregnant or breastfeeding, or expecting to conceive or the pregnancy test is positive at screening visit.
Participant is currently participating or has participated in a study with an investigational compound 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 (L100/H12.5)
MK-954HAlso: Preminent®Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily	Drug	MK-954H (L50/H12.5)
Placebo to MK-0954APlacebo tablet to match MK-0954A, once daily	Drug	MK-954H (L50/H12.5)
Placebo to MK-954HPlacebo tablet to match MK-954H, once daily	Drug	MK-0954A (L100/H12.5)

Primary outcome

Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)
Time frame: Up to 52 weeks

2 secondary outcomes

Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8
Time frame: Baseline and Week 8 (End of Double-blind Period)
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8
Time frame: Baseline and Week 8 (End of Double-blind Period)

Results and safety

Results posted to the registry on 6 Jan 2014, 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-0954H (L50/H12.5) Double Blind Period (Period 1)	144	131
MK-0954A (L100/H12.5) Double Blind Period (Period 1)	134	127
L50/H12.5→L100/H12.5 Open Label (Period 2)	0	0
L100/H12.5→L100/H12.5 Open Label (Period 2)	0	0

Primary outcome: Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension)

Time frame: Up to 52 weeks. Number. Unit: Percentage of Participants

Measure	L50/H12.5→L100/H12.5 Open Label (Period 2) n = 131	L100/H12.5→L100/H12.5 Open Label (Period 2) n = 134
Value	71.0	72.4

Population analysed: All-Patients-as-Treated (APaT) Population, which consists of all randomized patients who received at least one dose of MK-0954A. The L100/H12.5 (L50/H12.5) arm only includes data from extension period (44 weeks); L100/H12.5→L100/H12.5 Open Label arm includes data from entire study period (52 weeks).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-0954H (L50/H12.5) Double Blind Period (Period 1)	1 of 144 (0.7%)	18 of 144 (12.5%)	Not reported
MK-0954A (L100/H12.5) Double Blind Period (Period 1)	2 of 134 (1.5%)	20 of 134 (14.9%)	Not reported
L50/H12.5→L100/H12.5 Open Label (Period 2)	6 of 131 (4.6%)	47 of 131 (35.9%)	Not reported
L100/H12.5→L100/H12.5 Open Label (Period 2)	1 of 127 (0.8%)	43 of 127 (33.9%)	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

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.

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 MK-954H 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 6 Jan 2014). 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?

Percentage of Participants Who Experienced an Adverse Event When Receiving MK-0954A (L100/H12.5) During Study (8-week Double-blind and/or 44-week Open-label Extension) (time frame: Up to 52 weeks). 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 NCT01307033, 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.