HypertensionPhase 3NCT00886600

A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

A Phase 3 study testing losartan potassium and hydrochlorothiazide (HCTZ) 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

The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo. 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 hydrochlorothiazide (HCTZ)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: No sites listed yet
Study dates: May 1991to Aug 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

Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight
Patient is in good general health
Blood pressure at time of randomization is 95-115 mm Hg

Who cannot join

Secondary Hypertension or history of malignant hypertension
History of stroke
History of myocardial infarction
Atrial flutter or atrial fibrillation
History of congestive Heart failure
Patient taking major psychotropic agent or anti-depressant

Show all 17Show fewer

Patient regularly uses NSAIDS or high dose aspirin
Known positive test for HIV/AIDS or Hepatitis B
Patient is being treated for acute ulcer disease
Prior exposure to losartan
Actively treated diabetes mellitus
History of chronic liver disease
Actively treated diabetes mellitus
Any known bleeding or platelet disorder
Absence of one kidney
Women of childbearing potential
Alcoholism or drug addiction

About this study

Official title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Pilot Study to Investigate the Magnitude and Duration of Response and the Safety of MK0954 (50 mg Given Once or Twice Daily, or 100 mg Given Once Daily) Compared to Placebo Using Ambulatory Blood Pressure Monitoring

Conditions: Hypertension
Being tested: losartan potassium, Comparator: placebo, hydrochlorothiazide (HCTZ)
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 potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
Comparator: placeboDrug
placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
hydrochlorothiazide (HCTZ)Drug
Also called HCTZ
open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks

Study groups in NCT00886600
Study group	Role	What they receive
1	Placebo comparator	Placebo Receives: Drug: Comparator: placebo; Drug: hydrochlorothiazide (HCTZ)
2	Experimental	losartan 50 mg q.d. Receives: Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ)
3	Experimental	losartan 100 mg q.d. Receives: Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ)
4	Experimental	losartan 50 mg b.i.d. Receives: Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ)

What is being measured

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

Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
Measured: 24 hour period at Baseline and Week 4
Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
Measured: 24-hour period at baseline and Week 4

Secondary outcomes (3)

Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4
Measured: Baseline and 24-hours after morning dose at Week 4
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6
Measured: Baseline and 24-hours after morning dose at Week 6
Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6
Measured: Baseline and 24-hours after morning dose at Week 6

Timeline

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

May 1991Aug 1992

First posted23 Apr 2009 (estimated)
Study startMay 1991
Primary completionMay 1992
Study completionAug 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: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00886600
Sponsor's protocol ID: 0954-021
Other IDs: MK0954-021, 2009_581
Status last verified: Aug 2015
First submitted: 22 Apr 2009
Last updated: 27 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Weber MA, Byyny RL, Pratt JH, Faison EP, Snavely DB, Goldberg AI, Nelson EB. Blood pressure effects of the angiotensin II receptor blocker, losartan. Arch Intern Med. 1995 Feb 27;155(4):405-11.
PubMed 7848024

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 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Pilot Study to Investigate the Magnitude and Duration of Response and the Safety of MK0954 (50 mg Given Once or Twice Daily, or 100 mg Given Once Daily) Compared to Placebo Using Ambulatory Blood Pressure Monitoring
ClinicalTrials.gov ID: NCT00886600
Acronym / sponsor ID: 0954-021
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: May 1991
Primary completion: May 1992 (actual)
Study completion: Aug 1992 (actual)
First posted: 23 Apr 2009 (estimated)
Results: Posted 14 Jul 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: placebo, Drug: hydrochlorothiazide (HCTZ)Placebo
2	Experimental	Drug: losartan potassium, Drug: hydrochlorothiazide (HCTZ)losartan 50 mg q.d.
3	Experimental	Drug: losartan potassium, Drug: hydrochlorothiazide (HCTZ)losartan 100 mg q.d.
4	Experimental	Drug: losartan potassium, Drug: hydrochlorothiazide (HCTZ)losartan 50 mg b.i.d.

Who may qualify

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

Key inclusion criteria (3 listed)

Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight
Patient is in good general health
Blood pressure at time of randomization is 95-115 mm Hg

Key exclusion criteria (17 listed)

Secondary Hypertension or history of malignant hypertension
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: MK0954losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks	Drug	2, 3, 4
Comparator: placeboplacebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks	Drug	1
hydrochlorothiazide (HCTZ)Also: HCTZopen-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks	Drug	1, 2, 3, 4

Primary outcome

Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
Time frame: 24 hour period at Baseline and Week 4
Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
Time frame: 24-hour period at baseline and Week 4

3 secondary outcomes

Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4
Time frame: Baseline and 24-hours after morning dose at Week 4
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6
Time frame: Baseline and 24-hours after morning dose at Week 6
Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6
Time frame: Baseline and 24-hours after morning dose at Week 6

Results and safety

Results posted to the registry on 14 Jul 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 / HCTZ 12.5 mg	32	30
Losartan 50 mg q.d. / HCTZ 12.5 mg	29	28
Losartan 100 mg q.d. / HCTZ 12.5 mg	30	29
Losartan 50 mg b.i.d. / HCTZ 12.5 mg	31	29

Primary outcome: Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4

Time frame: 24 hour period at Baseline and Week 4. Mean (Standard Deviation). Unit: mm Hg

Measure	Placebo / HCTZ 12.5 mg n = 26	Losartan 50 mg q.d. / HCTZ 12.5 mg n = 28	Losartan 100 mg q.d. / HCTZ 12.5 mg n = 28	Losartan 50 mg b.i.d. / HCTZ 12.5 mg n = 30
Value	-0.2 (4.8)	-5.2 (5.1)	-6.4 (5.5)	-8.5 (6.7)

Population analysed: The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis.

Primary outcome: Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4

Time frame: 24-hour period at baseline and Week 4. Mean (Standard Deviation). Unit: mm Hg

Measure	Placebo / HCTZ 12.5 mg n = 26	Losartan 50 mg q.d. / HCTZ 12.5 mg n = 28	Losartan 100 mg q.d. / HCTZ 12.5 mg n = 28	Losartan 50 mg b.i.d. / HCTZ 12.5 mg n = 30
Value	0 (7.8)	-9.2 (9.9)	-9.9 (7.6)	-13.2 (10.6)

Population analysed: The efficacy analysis followed a "per protocol" approach in that only patients who completed the study according to the protocol were included in the analysis.

3 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 27 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7848024Weber MA, Byyny RL, Pratt JH, Faison EP, Snavely DB, Goldberg AI, Nelson EB. Blood pressure effects of the angiotensin II receptor blocker, losartan. Arch Intern Med. 1995 Feb 27;155(4):405-11.

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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
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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 hydrochlorothiazide (HCTZ) 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 17 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 14 Jul 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 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4 (time frame: 24 hour period at Baseline and Week 4). The study lists 2 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 NCT00886600, 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.