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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Enalapril; Drug: losartan potassium; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882440

MK0954-011

0954-011

2009_574

Details and patient eligibility

About

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.

Enrollment: 576 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

576 participants in 7 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

2

Experimental group

Description:

Losartan 10 mg

Treatment:

Drug: losartan potassium

3

Experimental group

Description:

Losartan 25 mg

Treatment:

Drug: losartan potassium

4

Experimental group

Description:

Losartan 50 mg

Treatment:

Drug: losartan potassium

5

Experimental group

Description:

Losartan 100 mg

Treatment:

Drug: losartan potassium

6

Experimental group

Description:

Losartan 150 mg

Treatment:

Drug: losartan potassium

7

Active Comparator group

Description:

Enalapril 20 mg

Treatment:

Drug: Enalapril