HypertensionPhase 3NCT00887250

A Study to Investigate the Antihypertensive Efficacy of MK0954

A Phase 3 study testing losartan potassium and Comparator: losartan 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 21 years and older
Conditions the study is for: Hypertension
What is being tested?: losartan potassium and Comparator: losartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 366 participants
Where: No sites listed yet
Study dates: Dec 1991to Nov 1992
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)
Patient has no medical problems or treatments that might effect their blood pressure

Who cannot join

Pregnant or lactating females
Patient has secondary hypertension or malignant hypertension
Sitting systolic blood pressure > 210 mm Hg
History of stroke
History of myocardial infarction with in past year
Current or prior history of heart failure

Show all 10Show fewer

Known hypersensitivity to losartan
Prior exposure to losartan
Patients known to be HIV positive
Patient is abusing or has abused alcohol or other drugs within the past 4 years

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan (MK954, DuP753) in Patients With Mild to

After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.

Conditions: Hypertension
Being tested: losartan potassium, Comparator: losartan, Comparator: Placebo
Medical subject headings: Hypertension

What participants receive

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

losartan potassiumDrug
Also called MK0954
50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.
Comparator: losartanDrug
Also called MK0954
50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.
Comparator: PlaceboDrug
Placebo to Losartan

Study groups in NCT00887250
Study group	Role	What they receive
1	Placebo comparator	Placebo Receives: Drug: Comparator: Placebo
2	Experimental	Losartan 50 mg for 12 weeks Receives: Drug: losartan potassium
3	Experimental	Losartan 50 mg titrated to 100 mg after 6 weeks Receives: Drug: Comparator: losartan

What is being measured

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

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12
Measured: At baseline and at 12 weeks (24 hours post dose)

Secondary outcomes (5)

Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6
Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.
Measured: 24 hours post dose at Week 6
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12
Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.
Measured: 24 hours post dose at Week 12
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6
Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6
Measured: At baseline and at 6 weeks (24 hours post dose)
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6
Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6
Measured: At baseline and at 6 weeks (24 hours post dose)
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12
Measured: At baseline and at 12 weeks (6 hours post dose)

Timeline

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

Dec 1991Nov 1992

First posted23 Apr 2009 (estimated)
Study startDec 1991
Primary completionAug 1992
Study completionNov 1992

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00887250
Sponsor's protocol ID: 2009_580
Other IDs: MK0954-050
Status last verified: Jul 2009
First submitted: 22 Apr 2009
Last updated: 14 Jul 2009
Results posted: Yes, on ClinicalTrials.gov

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 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan (MK954, DuP753) in Patients With Mild to
ClinicalTrials.gov ID: NCT00887250
Acronym / sponsor ID: 2009_580
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 366 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 1991
Primary completion: Aug 1992 (actual)
Study completion: Nov 1992 (actual)
First posted: 23 Apr 2009 (estimated)
Results: Posted 24 Jun 2009

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: 3

Arm	Type	Receives
1	Placebo comparator	Drug: Comparator: PlaceboPlacebo
2	Experimental	Drug: losartan potassiumLosartan 50 mg for 12 weeks
3	Experimental	Drug: Comparator: losartanLosartan 50 mg titrated to 100 mg after 6 weeks

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)
Patient has no medical problems or treatments that might effect their blood pressure

Key exclusion criteria (10 listed)

Pregnant or lactating females
Patient has secondary hypertension or malignant hypertension
Sitting systolic blood pressure > 210 mm Hg
History of stroke
History of myocardial infarction with in past year

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 potassiumAlso: MK095450 mg Losartan (MK0954) tablet taken once daily for 12 weeks.	Drug	2
Comparator: losartanAlso: MK095450 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.	Drug	3
Comparator: PlaceboPlacebo to Losartan	Drug	1

Primary outcome

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Time frame: At baseline and at 12 weeks (24 hours post dose)
Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12

5 secondary outcomes

Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6
Time frame: 24 hours post dose at Week 6
Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12
Time frame: 24 hours post dose at Week 12
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6
Time frame: At baseline and at 6 weeks (24 hours post dose)
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6
Time frame: At baseline and at 6 weeks (24 hours post dose)
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Time frame: At baseline and at 12 weeks (6 hours post dose)

Results and safety

Results posted to the registry on 24 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	116	98
Losartan 50 mg	127	115
Losartan 50/100 mg	123	110

Primary outcome: Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

Time frame: At baseline and at 12 weeks (24 hours post dose). Mean (Standard Deviation). Unit: mm Hg

Measure	Placebo n = 114	Losartan 50 mg n = 125	Losartan 50/100 mg n = 118
Value	-4.3 (6.7)	-7.9 (7.6)	-8.6 (7.7)

Population analysed: The primary analysis employed an "all patients treated" approach that included patients with at least one treatment period measurement. The last measurements of withdrawn patients were carried forward to subsequent timepoints. Missing data were estimated by carrying forward data from the last visit (excluding baseline) at which it was available.

5 secondary outcomes are reported in the full results.

Limitations and caveats (from the sponsor): Safety has been reported in the literature.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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
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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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing losartan potassium and Comparator: losartan 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 2 inclusion and 10 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 14 Jul 2009. 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 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 24 Jun 2009). 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?

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 (time frame: At baseline and at 12 weeks (24 hours post dose)). 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 NCT00887250.

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 14 Jul 2009.