Factorial Study of Metoprolol Succinate TOPROL-XL (324A)
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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
Last updated: March 24, 2009
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