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Phase 3 Completed N=576 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT00882440 ↗
Enrolled (actual)
576
Serious AEs
Results posted
Jun 2009
Primary outcomePrimary: Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8 — -5.6; -7.9; -6.8; -10.1 mm Hg

Summary

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change From Baseline in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
-5.6; -7.9; -6.8; -10.1; -9.9; -9.7
SECONDARY
Categories of Antihypertensive Response in Trough Supine Diastolic Blood Pressure (SuDBP) at Week 8
10; 19; 21; 24; 29; 28
SECONDARY
Mean Change From Baseline in Peak Supine Diastolic Blood Pressure (SuDBP) at Week 8
-4.7; -7.3; -9.9; -11.9; -10.4; -13.1

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00882440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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