HypertensionPhase 3NCT01302691

MK-0954E Study in Participants With Hypertension (MK-0954E-357)

A Phase 3 study testing losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E), Losartan potassium and Amlodipine besylate 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

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Hypertension
What is being tested?: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E), Losartan potassium and Amlodipine besylate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 327 participants
Where: No sites listed yet
Study dates: 1 Jan 2011to 1 Apr 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 single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
Participant has a mean trough SiDBP of ≥ 90 mmHg and < 110 mmHg.
Participant has a mean trough SiSBP of ≥ 140 mmHg and < 200 mmHg.
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, amlodipine or dihydropyridine drug, 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 (Visit 1).
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 Clinical Trial to Study the Efficacy and Safety of MK-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration

This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).

Conditions: Hypertension
Being tested: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E), Losartan potassium, Amlodipine besylate, Placebo to MK-0954E, Placebo to losartan potassium
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.

losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)Drug
One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
Losartan potassiumDrug
One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.
Amlodipine besylateDrug
One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
Placebo to MK-0954EDrug
One tablet, containing placebo, orally, once daily, for 8 weeks.
Placebo to losartan potassiumDrug
One tablet, containing placebo, orally, once daily, for 8 weeks.
Placebo to amlodipine besylateDrug
One capsule, containing placebo, orally, once daily, for 8 weeks.

Study groups in NCT01302691
Study group	Role	What they receive
L50/H12.5/A5	Experimental	Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks. Receives: Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E); Drug: Placebo to losartan potassium; Drug: Placebo to amlodipine besylate
L50 + A5	Active comparator	Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks. Receives: Drug: Losartan potassium; Drug: Amlodipine besylate; Drug: Placebo to MK-0954E

What is being measured

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

Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
Measured: Baseline and Week 8
Percentage of Participants Who Experience ≥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 at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.
Measured: up to 14 days after last dose of study drug (up to 10 weeks)
Percentage of Participants Who Experience ≥1 Drug-related 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. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.
Measured: up to 14 days after last dose of study drug (up to 10 weeks)
Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.
Measured: up to 14 days after last dose of study drug (up to 10 weeks)
Percentage of Participants Who Experience ≥1 Drug-related SAE
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received
Measured: up to 14 days after last dose of study drug (up to 10 weeks)
Percentage of Participants Who Had Study Drug Stopped Due to an 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 study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm
Measured: up to 8 weeks

Secondary outcomes (1)

Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
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.

1 Jan 20111 Apr 2012

First posted24 Feb 2011 (estimated)
Study start1 Jan 2011
Primary completion1 Apr 2012
Study completion1 Apr 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 (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01302691
Sponsor's protocol ID: 0954E-357
Status last verified: Feb 2019
First submitted: 22 Feb 2011
Last updated: 15 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension. Clin Exp Hypertens. 2015;37(3):260-6. doi: 10.3109/10641963.2014.954712. Epub 2014 Oct 1.
PubMed 25271811
Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg. Hypertens Res. 2015 May;38(5):329-35. doi: 10.1038/hr.2015.3. Epub 2015 Feb 26.
PubMed 25716649

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 15 Mar 2019. 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-0954E in Japanese Patients With Essential Hypertension Uncontrolled With Losartan and Amlodipine Co-administration
ClinicalTrials.gov ID: NCT01302691
Acronym / sponsor ID: 0954E-357
Conditions: Hypertension
Keywords: Essential hypertension, Uncontrolled hypertension, Antihypertensive agents, Blood pressure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 327 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 1 Jan 2011 (actual)
Primary completion: 1 Apr 2012 (actual)
Study completion: 1 Apr 2012 (actual)
First posted: 24 Feb 2011 (estimated)
Results: Posted 27 Jan 2017

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: 2

Arm	Type	Receives
L50/H12.5/A5	Experimental	Drug: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E), Drug: Placebo to losartan potassium, Drug: Placebo to amlodipine besylateParticipants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
L50 + A5	Active comparator	Drug: Losartan potassium, Drug: Amlodipine besylate, Drug: Placebo to MK-0954EParticipants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), 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 being treated with single or dual treatment for hypertension and will be able to discontinue the prior antihypertensive medication.
Participant has a mean trough SiDBP of ≥ 90 mmHg and < 110 mmHg.
Participant has a mean trough SiSBP of ≥ 140 mmHg and < 200 mmHg.
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, amlodipine or dihydropyridine drug, 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 (Visit 1).
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
losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.	Drug	L50/H12.5/A5
Losartan potassiumOne tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.	Drug	L50 + A5
Amlodipine besylateOne capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.	Drug	L50 + A5
Placebo to MK-0954EOne tablet, containing placebo, orally, once daily, for 8 weeks.	Drug	L50 + A5
Placebo to losartan potassiumOne tablet, containing placebo, orally, once daily, for 8 weeks.	Drug	L50/H12.5/A5
Placebo to amlodipine besylateOne capsule, containing placebo, orally, once daily, for 8 weeks.	Drug	L50/H12.5/A5

Primary outcome

Change in Mean 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 at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
Percentage of Participants Who Experience ≥1 Adverse Event (AE)
Time frame: up to 14 days after last dose of study drug (up to 10 weeks)
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 at least 1 AE during the 10-week treatment and follow-up period were summarized by study drug received.
Percentage of Participants Who Experience ≥1 Drug-related AE
Time frame: up to 14 days after last dose of study drug (up to 10 weeks)
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. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received.
Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)
Time frame: up to 14 days after last dose of study drug (up to 10 weeks)
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 10-week treatment and follow-up period were summarized by study drug received.
Percentage of Participants Who Experience ≥1 Drug-related SAE
Time frame: up to 14 days after last dose of study drug (up to 10 weeks)
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 10-week treatment and follow-up period were summarized by study drug received
Percentage of Participants Who Had Study Drug Stopped Due to an AE
Time frame: up to 8 weeks
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 study drug stopped during the 8-week treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm

1 secondary outcome

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

Results and safety

Results posted to the registry on 27 Jan 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
L50/H12.5/A5	164	154
L50 + A5	163	157

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

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

Measure	L50/H12.5/A5 n = 164	L50 + A5 n = 163
Value	-9.1 (-10.2 to -7.9)	-8.0 (-9.1 to -6.8)

L50/H12.5/A5 vs L50 + A5: Difference in Least Squares Means: -1.1 (95% CI -2.7 to 0.6), p = 0.205, Constrained Longitudinal Data Analysis

Population analysed: All participants that received at least one dose of study treatment, had at least 1 post-randomization observation for the analysis endpoint, and had baseline data

Primary outcome: Percentage of Participants Who Experience ≥1 Adverse Event (AE)

Time frame: up to 14 days after last dose of study drug (up to 10 weeks). Number. Unit: Percentage of Participants

Measure	L50/H12.5/A5 n = 164	L50 + A5 n = 163
Value	30.5	28.8

Population analysed: All randomized participants who received at least 1 dose of study drug.

Primary outcome: Percentage of Participants Who Experience ≥1 Drug-related AE

Time frame: up to 14 days after last dose of study drug (up to 10 weeks). Number. Unit: Percentage of Participants

Measure	L50/H12.5/A5 n = 164	L50 + A5 n = 163
Value	11.6	3.7

Population analysed: All randomized participants who received at least 1 dose of study drug.

Primary outcome: Percentage of Participants Who Experience ≥1 Serious Adverse Event (SAE)

Time frame: up to 14 days after last dose of study drug (up to 10 weeks). Number. Unit: Percentage of Participants

Measure	L50/H12.5/A5 n = 164	L50 + A5 n = 163
Value	0.6	0.6

Population analysed: All randomized participants who received at least 1 dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: up to 2 weeks after last dose of study drug (up to 10 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
L50/H12.5/A5	1 of 164 (0.6%)	11 of 164 (6.7%)	Not reported
L50 + A5	1 of 163 (0.6%)	15 of 163 (9.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25271811Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Efficacy and safety of fixed-dose losartan/hydrochlorothiazide/amlodipine combination versus losartan/hydrochlorothiazide combination in Japanese patients with essential hypertension. Clin Exp Hypertens. 2015;37(3):260-6. doi: 10.3109/10641963.2014.954712. Epub 2014 Oct 1.
Results publication: PubMed 25716649Rakugi H, Tsuchihashi T, Shimada K, Numaguchi H, Nishida C, Yamaguchi H, Shirakawa M, Azuma K, Fujita KP. Add-on effect of hydrochlorothiazide 12.5 mg in Japanese subjects with essential hypertension uncontrolled with losartan 50 mg and amlodipine 5 mg. Hypertens Res. 2015 May;38(5):329-35. doi: 10.1038/hr.2015.3. Epub 2015 Feb 26.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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?

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 15 Mar 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 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 27 Jan 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 in Mean Trough Sitting Diastolic Blood Pressure (SiDBP) (time frame: Baseline and Week 8). 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 NCT01302691, which also lists 2 linked publications.

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 15 Mar 2019.