HypertensionPhase 3NCT00882440

A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)

A Phase 3 study testing losartan potassium and Enalapril 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 purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmHg. 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 and Enalapril
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 576 participants
Where: No sites listed yet
Study dates: Dec 1990to Jan 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, with supine diastolic blood pressure of 100 to 115 mmHg
Patient has no active medical problems other than essential hypertension that might affect blood pressure
Patient has received no drug therapy that might affect blood pressure

Who cannot join

Prior exposure to losartan
History of stroke
History of myocardial infarction
Atrial flutter or atrial fibrillation
History of congestive Heart failure
Known Sensitivity to ACE inhibitors

Show all 14Show fewer

Known positive test for HIV/AIDS or Hepatitis B
Patient is being treated for acute ulcer disease
History of chronic liver disease
Actively treated diabetes mellitis
Any known bleeding or platelet disorder
Absence of one kidney
Women of childbearing potential or who are breastfeeding
Patient is abusing or has a history of alcoholism or drug addiction

About this study

Official title: A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Different Doses of DuP 753 (MK0954)

Conditions: Hypertension
Being tested: losartan potassium, Placebo, Enalapril
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, Cozaar
losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks
PlaceboDrug
Placebo capsule to losartan
EnalaprilDrug
Enalapril 20 mg oral tablet taken once daily for 8 weeks

Study groups in NCT00882440
Study group	Role	What they receive
1	Placebo comparator	Placebo Receives: Drug: Placebo
2	Experimental	Losartan 10 mg Receives: Drug: losartan potassium
3	Experimental	Losartan 25 mg Receives: Drug: losartan potassium
4	Experimental	Losartan 50 mg Receives: Drug: losartan potassium
5	Experimental	Losartan 100 mg Receives: Drug: losartan potassium
6	Experimental	Losartan 150 mg Receives: Drug: losartan potassium
7	Active comparator	Enalapril 20 mg Receives: Drug: Enalapril

What is being measured

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

Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
Measured: 24 hours post dose at Baseline and Week 8

Secondary outcomes (2)

Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
Patients in Category I (defined as "excellent" in protocol) if SuDBP was <90 mmHg, Category II (defined as "good" in protocol) if SuDBP was ≥90 but decreased at least 10 mmHg, or Category III (defined as "fair" or "inadequate" in protocol) if SuDBP was ≥90 and decreased less than 10 mmHg.
Measured: 24 hours post dose at Week 8
Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8
Measured: 6 hours post dose at Baseline and 8 weeks

Timeline

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

Dec 1990Jan 1992

First posted16 Apr 2009 (estimated)
Study startDec 1990
Primary completionAug 1991
Study completionJan 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.
Publications (1)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: 576 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00882440
Sponsor's protocol ID: 0954-011
Other IDs: MK0954-011, 2009_574
Status last verified: Aug 2015
First submitted: 14 Apr 2009
Last updated: 27 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Gradman AH, Arcuri KE, Goldberg AI, Ikeda LS, Nelson EB, Snavely DB, Sweet CS. A randomized, placebo-controlled, double-blind, parallel study of various doses of losartan potassium compared with enalapril maleate in patients with essential hypertension. Hypertension. 1995 Jun;25(6):1345-50. doi: 10.1161/01.hyp.25.6.1345.
PubMed 7768585

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 27 Aug 2015. 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 Different Doses of DuP 753 (MK0954)
ClinicalTrials.gov ID: NCT00882440
Acronym / sponsor ID: 0954-011
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 576 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 1990
Primary completion: Aug 1991 (actual)
Study completion: Jan 1992 (actual)
First posted: 16 Apr 2009 (estimated)
Results: Posted 10 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: 7

Arm	Type	Receives
1	Placebo comparator	Drug: PlaceboPlacebo
2	Experimental	Drug: losartan potassiumLosartan 10 mg
3	Experimental	Drug: losartan potassiumLosartan 25 mg
4	Experimental	Drug: losartan potassiumLosartan 50 mg
5	Experimental	Drug: losartan potassiumLosartan 100 mg
6	Experimental	Drug: losartan potassiumLosartan 150 mg
7	Active comparator	Drug: EnalaprilEnalapril 20 mg

Who may qualify

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

Key inclusion criteria (3 listed)

Patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmHg
Patient has no active medical problems other than essential hypertension that might affect blood pressure
Patient has received no drug therapy that might affect blood pressure

Key exclusion criteria (14 listed)

Prior exposure to losartan
History of stroke
History of myocardial infarction
Atrial flutter or atrial fibrillation
History of congestive Heart failure

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: MK0954, Cozaarlosartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks	Drug	2, 3, 4, 5, 6
PlaceboPlacebo capsule to losartan	Drug	1
EnalaprilEnalapril 20 mg oral tablet taken once daily for 8 weeks	Drug	7

Primary outcome

Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
Time frame: 24 hours post dose at Baseline and Week 8

2 secondary outcomes

Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
Time frame: 24 hours post dose at Week 8
Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8
Time frame: 6 hours post dose at Baseline and 8 weeks

Results and safety

Results posted to the registry on 10 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	78	67
Losartan 10 mg	80	72
Losartan 25 mg	82	75
Losartan 50 mg	79	76
Losartan 100 mg	90	80
Losartan 150 mg	84	77
Enalapril 20	83	79

Primary outcome: Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8

Time frame: 24 hours post dose at Baseline and Week 8. Mean (Standard Deviation). Unit: mm Hg

Measure	Placebo n = 78	Losartan 10 mg n = 80	Losartan 25 mg n = 82	Losartan 50 mg n = 78	Losartan 100 mg n = 89	Losartan 150 mg n = 84	Enalapril 20 n = 82
Value	-5.6 (7.8)	-7.9 (7.6)	-6.8 (7.9)	-10.1 (7.0)	-9.9 (6.9)	-9.7 (8.0)	-11.2 (6.7)

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.

2 secondary outcomes are reported in the full results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7768585Gradman AH, Arcuri KE, Goldberg AI, Ikeda LS, Nelson EB, Snavely DB, Sweet CS. A randomized, placebo-controlled, double-blind, parallel study of various doses of losartan potassium compared with enalapril maleate in patients with essential hypertension. Hypertension. 1995 Jun;25(6):1345-50. doi: 10.1161/01.hyp.25.6.1345.

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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.

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 Enalapril 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 3 inclusion and 14 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 27 Aug 2015. 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 10 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 Supine Diastolic Blood Pressure (SuDBP) at Week 8 (time frame: 24 hours post dose at Baseline and Week 8). 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 NCT00882440, 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 27 Aug 2015.