Factorial Study of Metoprolol Succinate TOPROL-XL (324A)

Overview

The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. The study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.

Full Title of Study: “A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Factorial Study of Metoprolol Succinate Extended Release Tablets (TOPROL-XL) Hydrochlorothiazide and Their Combination in Patients With Essential Hypertension.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: July 2004

Interventions

  • Drug: Metoprolol Succinate
  • Drug: Hydrochlorothiazide

Arms, Groups and Cohorts

  • Experimental: 1
    • Metoprolol Succinate + Hydrochlorothiazide
  • Active Comparator: 2
    • Metoprolol Succinate
  • Active Comparator: 3
    • Hydrochlorothiazide

Clinical Trial Outcome Measures

Primary Measures

  • Change in trough sitting diastolic blood pressure
    • Time Frame: 3 readings determined at 8 weeks after treatment

Secondary Measures

  • change in trough Sitting Systolic Blood pressure
    • Time Frame: 3 readings determined at 8 weeks after treatment
  • change in trough Standing Systolic Blood Pressure
    • Time Frame: 6 readings determined at 8 weeks after treatment
  • change in trough standing diastolic blood pressure
    • Time Frame: 6 readings determined at 8 weeks after treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Diastolic blood pressure between 95 and 114 mm at screening and start of treatment Exclusion Criteria:

  • Significant conditions which in the opinion of the investigator place the subject at undue risk, eg Renal impairment, hepatitis – Known secondary causes of hypertension, eg, Cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism – Systolic blood pressure greater or equal to 180 mm Hg at start of trial

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Overall Official(s)
    • Vasilios Papademetriou, Principal Investigator, Georgetown University

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