Factorial Study of Metoprolol Succinate TOPROL-XL (324A)
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: High Blood Pressure (Hypertension).
Intervention: Metoprolol Succinate (Drug); Hydrochlorothiazide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Vasilios Papademetriou, Principal Investigator, Affiliation: Georgetown University
Summary
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.
Clinical Details
Official title: 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 design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in trough sitting diastolic blood pressure
Secondary outcome: change in trough Sitting Systolic Blood pressurechange in trough Standing Systolic Blood Pressure change in trough standing diastolic blood pressure
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: June 2003
Ending date: October 2004
Last updated: March 18, 2008
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