A Study to Investigate the Antihypertensive Efficacy of MK0954

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: losartan potassium; Drug: Comparator: Placebo; Drug: Comparator: losartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00887250

MK0954-050

2009_580

Details and patient eligibility

About

After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.

Enrollment: 366 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)
• Patient has no medical problems or treatments that might effect their blood pressure

Exclusion criteria

• Pregnant or lactating females
• Patient has secondary hypertension or malignant hypertension
• Sitting systolic blood pressure > 210 mm Hg
• History of stroke
• History of myocardial infarction with in past year
• Current or prior history of heart failure
• Known hypersensitivity to losartan
• Prior exposure to losartan
• Patients known to be HIV positive
• Patient is abusing or has abused alcohol or other drugs within the past 4 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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366 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo

2

Experimental group

Description:

Losartan 50 mg for 12 weeks

Treatment:

Drug: losartan potassium

3

Experimental group

Description:

Losartan 50 mg titrated to 100 mg after 6 weeks

Treatment:

Drug: Comparator: losartan