HypertensionPhase 3NCT00888355

MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

A Phase 3 study testing losartan potassium 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.

Trial summary

The study had a 4 week single blind placebo period followed by 12 weeks of double blind treatment. Patients were randomized to one of four treatment arms to evaluate the antihypertensive efficacy of Losartan. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Hypertension
What is being tested?: losartan potassium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 428 participants
Where: No sites listed yet
Study dates: May 1992to Feb 1993
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
Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure

Who cannot join

Pregnant of lactating female patients
Secondary hypertension or history of malignant hypertension
Sitting systolic blood pressure > 210 mmHg
History of stroke
History of myocardial infarction with in the past year
Current of prior history of heart failure

Show all 11Show fewer

Known hypersensitivity to losartan
Obesity
Patients known to be HIV positive or known to be positive for Hepatitis B
Absence of one kidney
Patient is abusing or previously abused alcohol or drugs with in past two years

About this study

Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Losartan Given Once or Twice Daily in Patients With Mild to Moderate Hypertension

Conditions: Hypertension
Being tested: losartan potassium, 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
losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
Comparator: placeboDrug
placebo to losartan tablet q.a.m. , for 12 weeks

Study groups in NCT00888355
Study group	Role	What they receive
1	Placebo comparator	Placebo Receives: Drug: Comparator: placebo
2	Experimental	Losartan 50 q.a.m. Receives: Drug: losartan potassium
3	Experimental	Losartan 25 b.i.d. Receives: Drug: losartan potassium
4	Experimental	Losartan 25 q.a.m. Receives: Drug: losartan potassium

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 after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12
Measured: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)

Secondary outcomes (3)

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12
Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12
Measured: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose)
Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12
Measured: At baseline and at 12 weeks (6 hours after last morning dose)
Categories of Antihypertensive Response in Trough Sitting 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 or increased were in Category III.
Measured: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks

Timeline

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

May 1992Feb 1993

First posted27 Apr 2009 (estimated)
Study startMay 1992
Primary completionJan 1993
Study completionFeb 1993

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: 428 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00888355
Sponsor's protocol ID: 2009_582
Other IDs: MK0954-065
Status last verified: Jul 2009
First submitted: 24 Apr 2009
Last updated: 9 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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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Losartan Given Once or Twice Daily in Patients With Mild to Moderate Hypertension
ClinicalTrials.gov ID: NCT00888355
Acronym / sponsor ID: 2009_582
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 428 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 1992
Primary completion: Jan 1993 (actual)
Study completion: Feb 1993 (actual)
First posted: 27 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: 4

Arm	Type	Receives
1	Placebo comparator	Drug: Comparator: placeboPlacebo
2	Experimental	Drug: losartan potassiumLosartan 50 q.a.m.
3	Experimental	Drug: losartan potassiumLosartan 25 b.i.d.
4	Experimental	Drug: losartan potassiumLosartan 25 q.a.m.

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
Patient has no treatment or active medical problem, other than hypertension that might affect the patients blood pressure

Key exclusion criteria (11 listed)

Pregnant of lactating female patients
Secondary hypertension or history of malignant hypertension
Sitting systolic blood pressure > 210 mmHg
History of stroke
History of myocardial infarction with in the 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: MK0954losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks	Drug	2, 3, 4
Comparator: placeboplacebo to losartan tablet q.a.m. , for 12 weeks	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 after last morning dose and 12 hours after last PM dose)
Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12

3 secondary outcomes

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12
Time frame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM 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 after last morning dose)
Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12
Time frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks

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	108	86
Losartan 25 mg q.d.	108	99
Losartan 50 mg q.d.	106	94
Losartan 25 mg (b.i.d.)	106	96

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 after last morning dose and 12 hours after last PM dose). Mean (Standard Deviation). Unit: mm Hg

Measure	Placebo n = 102	Losartan 25 mg q.d. n = 105	Losartan 50 mg q.d. n = 101	Losartan 25 mg (b.i.d.) n = 101
Value	-2.0 (8.4)	-5.8 (6.7)	-6.3 (7.4)	-8.0 (7.9)

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.

3 secondary outcomes are reported in the full results.

Limitations and caveats (from the sponsor): Note that deaths are not entered under "drop reasons" in the participant flow panel because the patients who died are already counted as dropped due to adverse event.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Hypertension (Without Type 2 Diabetes Mellitus)
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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.

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 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 11 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 9 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 after last morning dose and 12 hours after last PM 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 NCT00888355.

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 9 Jul 2009.