CompletedNCT00886600Updated Aug 27, 2015Results posted

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 interventional study of losartan potassium and Comparator: placebo in Hypertension, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-08-27.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 122
Allocation: Randomized
Ages: 21 Years and older
Sex: All

Study 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.

Conditions studied

Hypertension

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Hypertension 6,689

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 122 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 122 participants (actual)

Study arms

Placebo comparator
1
Placebo
Drug: Comparator: placebo · Drug: hydrochlorothiazide (HCTZ)
Experimental
2
losartan 50 mg q.d.
Drug: losartan potassium · Drug: hydrochlorothiazide (HCTZ)
Experimental
3
losartan 100 mg q.d.
Drug: losartan potassium · Drug: hydrochlorothiazide (HCTZ)
Experimental
4
losartan 50 mg b.i.d.
Drug: losartan potassium · Drug: hydrochlorothiazide (HCTZ)

Interventions

Druglosartan potassium
losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
Also known as: MK0954
DrugComparator: placebo
placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks
Drughydrochlorothiazide (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
Also known as: HCTZ

What researchers measure

Primary outcomes

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

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

Posted Jul 14, 2009

Limitations and caveats

Safety has been reported in the literature.

Participant flow

Patients were recruited at 9 sites in the United States. Prime Therapy Period: May, 1991 to March, 1992.

Double-blind Monotherapy

Participant flow — Double-blind Monotherapy
Milestone	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Started	32	29	30	31
Completed	30	28	29	29
Not completed	2	1	1	2
Withdrew: Adverse event	1	1	1	1
Withdrew: Protocol violation	0	0	0	1
Withdrew: Withdrawal by subject	1	0	0	0

Combination Therapy Period

Participant flow — Combination Therapy Period
Milestone	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Started	28	21	21	23
Completed	28	21	19	23
Not completed	0	0	2	0
Withdrew: Adverse event	0	0	1	0
Withdrew: Protocol violation	0	0	1	0

Outcome measures

PrimaryMean 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
Reported as:: Mean · mm Hg

Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
mm Hg	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4	-0.2 ± 4.8	-5.2 ± 5.1	-6.4 ± 5.5	-8.5 ± 6.7

PrimaryMean 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
Reported as:: Mean · mm Hg

Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4
mm Hg	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4	0 ± 7.8	-9.2 ± 9.9	-9.9 ± 7.6	-13.2 ± 10.6

SecondaryMean 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
Reported as:: Mean · mm Hg

Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4
mm Hg	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4	-2.1 ± 6.9	-6.7 ± 7.8	-9.6 ± 6.5	-8.8 ± 7.8

SecondaryMean 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
Reported as:: Mean · mm Hg

Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6
mm Hg	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6	-4.6 ± 6.1	-9.9 ± 6.3	-10.7 ± 4.9	-10.1 ± 7.8

SecondaryMean 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
Reported as:: Mean · mm Hg

Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6
mm Hg	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg
Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6	-4.0 ± 6.4	-5.1 ± 7.8	-4.0 ± 6.1	-4.0 ± 6.9

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg	Total
Mean	52.2 ± 12.0	56.8 ± 12.1	51.2 ± 9.6	54.1 ± 9.0	53.5 ± 10.8

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg	Total
Female	7	10	9	13	39
Male	25	19	21	18	83

Race/Ethnicity
Race/Ethnicity(participants)	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg	Total
Caucasian	30	29	30	30	119
Oriental	0	0	0	1	1
Filipino	1	0	0	0	1
Indian	1	0	0	0	1

Diastolic 24-hr mean ambulatory blood pressure monitoring (ABPM)
Diastolic 24-hr mean ambulatory blood pressure monitoring (ABPM)(mm Hg)	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg	Total
Mean	94.8 ± 5.9	94.0 ± 6.9	93.8 ± 6.0	94.4 ± 6.9	94.2 ± 6.4

Sitting Diastolic Blood Pressure (SiDBP)
Sitting Diastolic Blood Pressure (SiDBP)(mm Hg)	Placebo / HCTZ 12.5 mg	Losartan 50 mg q.d. / HCTZ 12.5 mg	Losartan 100 mg q.d. / HCTZ 12.5 mg	Losartan 50 mg b.i.d. / HCTZ 12.5 mg	Total
Mean	100.7 ± 4.0	100.0 ± 4.6	101.5 ± 5.1	101.2 ± 4.8	100.9 ± 4.6

Study locations

No study locations are listed for this record.

References and documents

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. Erratum In: Arch Intern Med 1995 Apr 24;155(8):876. PubMed 7848024 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00886600
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Apr 23, 2009
Start date: May 1991
Primary completion: May 1992
Completion: Aug 1992
Results posted: Jul 14, 2009
Last update: Aug 27, 2015

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

View the source record on ClinicalTrials.gov ↗

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