MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: losartan potassium; Drug: Comparator: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00888355

MK0954-065

2009_582

Details and patient eligibility

About

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.

Enrollment: 428 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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428 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: placebo

2

Experimental group

Description:

Losartan 50 q.a.m.

Treatment:

Drug: losartan potassium

3

Experimental group

Description:

Losartan 25 b.i.d.

Treatment:

Drug: losartan potassium

4

Experimental group

Description:

Losartan 25 q.a.m.

Treatment:

Drug: losartan potassium