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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Comparator: placebo; Drug: losartan potassium; Drug: hydrochlorothiazide (HCTZ)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00886600

0954-021

2009_581

MK0954-021

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: placebo

Drug: hydrochlorothiazide (HCTZ)

2

Experimental group

Description:

losartan 50 mg q.d.

Treatment:

Drug: hydrochlorothiazide (HCTZ)

Drug: losartan potassium

3

Experimental group

Description:

losartan 100 mg q.d.

Treatment:

Drug: hydrochlorothiazide (HCTZ)

Drug: losartan potassium

4

Experimental group

Description:

losartan 50 mg b.i.d.

Treatment:

Drug: hydrochlorothiazide (HCTZ)

Drug: losartan potassium