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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


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 pressure

change in trough Standing Systolic Blood Pressure

change in trough standing diastolic blood pressure


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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