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Completed

NCT Number: NCT00886600

A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

The purpose of this study was to evaluate the magnitude and durations of the antihypertensive effects of losartan using ambulatory blood pressure monitoring (ABPM), and to evaluate the safety of losartan 50 and 100 mg doses compared to placebo.

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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

  • Non-black men and women with mild to moderate hypertension and within 30% of their ideal body weight
  • Patient is in good general health
  • Blood pressure at time of randomization is 95-115 mm Hg

Exclusion criteria

  • Secondary Hypertension or history of malignant hypertension
  • History of stroke
  • History of myocardial infarction
  • Atrial flutter or atrial fibrillation
  • History of congestive Heart failure
  • Patient taking major psychotropic agent or anti-depressant
  • Patient regularly uses NSAIDS or high dose aspirin
  • Known positive test for HIV/AIDS or Hepatitis B
  • Patient is being treated for acute ulcer disease
  • Prior exposure to losartan
  • Actively treated diabetes mellitus
  • History of chronic liver disease
  • Actively treated diabetes mellitus
  • Any known bleeding or platelet disorder
  • Absence of one kidney
  • Women of childbearing potential
  • Alcoholism or drug addiction

Treatment and study plan

Losartan Potassium

Drug

losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

Other names: MK0954

Comparator: placebo

Drug

placebo capsules to losartan potassium (50 or 100 mg) administered orally once daily (q.d.)or twice daily (b.i.d) for four weeks

Hydrochlorothiazide (HCTZ)

Drug

open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with Sitting Diastolic Blood Pressure (SiDBP) ≥85 mm Hg after 4 weeks of losartan monotherapy (Combination Therapy Period)) orally once daily (q.d.) for 2 weeks

Other names: HCTZ

Primary outcomes

  1. Mean Change From Baseline in 24-hour Diastolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4

    Time frame: 24 hour period at Baseline and Week 4

  2. Mean Change From Baseline in 24-hour Systolic Ambulatory Blood Pressure Monitoring (ABPM) at Week 4

    Time frame: 24-hour period at baseline and Week 4

Secondary outcomes

  1. Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) 24 Hours After Morning Dose at Week 4

    Time frame: Baseline and 24-hours after morning dose at Week 4

  2. Mean Change From Baseline in Sitting Diastolic Blood Pressure (siDBP) After Adding HCTZ 24 Hours After Morning Dose at Week 6

    Time frame: Baseline and 24-hours after morning dose at Week 6

  3. Mean Change From Week 4 in Sitting Diastolic Blood Pressure (siDBP) Adding HCTZ 24 Hours After Morning Dose at Week 6

    Time frame: Baseline and 24-hours after morning dose at Week 6

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Double-blind, Randomized, Parallel-group, Placebo-controlled Pilot Study to Investigate the Magnitude and Duration of Response and the Safety of MK0954 (50 mg Given Once or Twice Daily, or 100 mg Given Once Daily) Compared to Placebo Using Ambulatory Blood Pressure Monitoring

Important dates

Study start
1991
Primary completion
1992
Study completion
1992
First posted
Apr 23, 2009
Registry last updated
Aug 27, 2015

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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