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OpenTrials
Completed

NCT Number: NCT00887250

A Study to Investigate the Antihypertensive Efficacy of MK0954

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Losartan Potassium

Drug

50 mg Losartan (MK0954) tablet taken once daily for 12 weeks.

Other names: MK0954

Comparator: losartan

Drug

50 mg tablet of Losartan (MK0954) taken once daily for 6 weeks, Non-responders will then have the dose up titrated to 100 mg for remaining 6 weeks.

Other names: MK0954

Comparator: placebo

Drug

Placebo to Losartan

Primary outcomes

  1. Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

    Time frame: At baseline and at 12 weeks (24 hours post dose)

    Mean change from baseline in trough (24 hours post dose) SiDBP at Week 12

Secondary outcomes

  1. Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 6

    Time frame: 24 hours post dose at Week 6

    Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.

  2. Categories of Hypertensive Response in Trough Diastolic Blood Pressure (SiDBP) at Week 12

    Time frame: 24 hours post dose at Week 12

    Patients with trough SiDBP <90 mm Hg were in Category I, ≥90 but decreased at least 10 mm Hg were in Category II, and ≥90 and decreased less than 10 mm Hg were in Category III.

  3. Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 6

    Time frame: At baseline and at 6 weeks (24 hours post dose)

    Mean change from baseline in trough (24 hours post dose) SiDBP at Week 6

  4. Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 6

    Time frame: At baseline and at 6 weeks (24 hours post dose)

    Mean change from baseline in peak (6 hours post dose) SiDBP at Week 6

  5. Mean Change From Baseline in Peak Sitting Diastolic Blood Pressure (SiDBP) at Week 12

    Time frame: At baseline and at 12 weeks (6 hours post dose)

    Mean change from baseline in peak (6 hours post dose) SiDBP at Week 12

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan (MK954, DuP753) in Patients With Mild to

Important dates

Study start
1991
Primary completion
1992
Study completion
1992
First posted
Apr 23, 2009
Registry last updated
Jul 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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