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OpenTrials
Completed

NCT Number: NCT00888355

MK0954 Versus Placebo for Treatment of Mild to Moderate Hypertension

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.

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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
  • 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

Treatment and study plan

Losartan Potassium

Drug

losartan tablet (MK0954) 25 or 50 mg q.a.m. or 25 mg b.i.d., for 12 weeks

Other names: MK0954

Comparator: placebo

Drug

placebo to losartan tablet q.a.m. , for 12 weeks

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 after last morning dose and 12 hours after last PM dose)

    Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiDBP at Week 12

Secondary outcomes

  1. 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)

    Mean change from baseline in trough (24 hours after the last morning dose and 12 hours after the last PM dose) SiSBP at Week 12

  2. 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)

    Mean change from baseline in peak (6 hours after the last morning dose) SiDBP at Week 12

  3. 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

    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 or increased were in Category III.

Other outcomes

  1. Number of Patients With Clinical Adverse Experiences (CAEs)

    Time frame: 12 weeks

    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

  2. Number of Patients With Serious CAEs

    Time frame: 12 weeks

    Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

  3. Number of Patients With Drug-related CAEs

    Time frame: 12 weeks

    Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs during the 12-week treatment period

  4. Number of Patients Discontinued Due to CAEs

    Time frame: 12 weeks

    Patients discontinued due to CAEs during the 12-week treatment period

  5. Number of Patients Who Died

    Time frame: 12 weeks

    Patients who died during the 12-week treatment period

  6. Number of Patients With Laboratory Adverse Experiences (LAEs)

    Time frame: 12 weeks

    A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product

  7. Number of Patients With Serious LAEs

    Time frame: 12 weeks

    Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose

  8. Number of Patients With Drug-related LAEs

    Time frame: 12 weeks

    Patients with drug-related LAEs during the 12-week treatment period

  9. Number of Patients Discontinued Due to LAEs

    Time frame: 12 weeks

    Patients discontinued due to LAEs during the 12-week treatment period

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Investigate the Antihypertensive Efficacy and Safety of Losartan Given Once or Twice Daily in Patients With Mild to Moderate Hypertension

Important dates

Study start
1992
Primary completion
1993
Study completion
1993
First posted
Apr 27, 2009
Registry last updated
Jul 9, 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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