MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

• Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) as Week 12 [ Time Frame: At baseline, and at 12 weeks (24 hours after last morning dose and 12 hours after last PM dose) ] [ Designated as safety issue: No ]
• Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: At baseline and at 12 weeks (6 hours after last morning dose) ] [ Designated as safety issue: No ]
• Categories of Antihypertensive Response in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks ] [ Designated as safety issue: No ]

• Mean change from baseline in trough sitting systolic blood pressure (SiSBP) as Week 12 [ Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks ] [ Designated as safety issue: No ]
• Mean change from baseline in peak sitting diastolic blood pressure (SiDBP) at Week 12 [ Time Frame: 6 hours after last morning dose at 12 weeks ] [ Designated as safety issue: No ]
• Categories of antihypertensive response in trough sitting diastolic blood pressure (SiDBP) at Week 12 [ Time Frame: 24 hours after last morning dose and 12 hours after last PM dose at 12 weeks ] [ Designated as safety issue: No ]
• Number of patients with clinical adverse experiences (CAEs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Number of patients with serious CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Number of patients with drug-related CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Number of patients discontinued due to CAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Number of patients who died [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Number of patients with laboratory adverse experiences (LAEs) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Number of patients with serious LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Number of patients with drug-related LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Number of patients discontinued due to LAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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.

• Drug: losartan potassium
  losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks
  Other Name: MK0954
• Drug: Comparator: placebo
  placebo to losartan tablet q.a.m. , for 12 weeks

• Placebo Comparator: 1
  Placebo
  Intervention: Drug: Comparator: placebo
• Experimental: 2
  Losartan 50 q.a.m.
  Intervention: Drug: losartan potassium
• Experimental: 3
  Losartan 25 b.i.d.
  Intervention: Drug: losartan potassium
• Experimental: 4
  Losartan 25 q.a.m.
  Intervention: Drug: losartan potassium

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