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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 18, 2008
Last updated: March 24, 2009
Last verified: March 2009
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.

Condition Intervention Phase
High Blood Pressure (Hypertension).
Drug: Metoprolol Succinate
Drug: Hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in trough sitting diastolic blood pressure [ Time Frame: 3 readings determined at 8 weeks after treatment ]

Secondary Outcome 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 ]

Estimated Enrollment: 1900
Study Start Date: June 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Metoprolol Succinate + Hydrochlorothiazide
Drug: Metoprolol Succinate
Other Name: TOPROL-XL
Drug: Hydrochlorothiazide
Active Comparator: 2
Metoprolol Succinate
Drug: Metoprolol Succinate
Other Name: TOPROL-XL
Active Comparator: 3
Drug: Hydrochlorothiazide


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00642096

Sponsors and Collaborators
Principal Investigator: Vasilios Papademetriou Georgetown University
  More Information Identifier: NCT00642096     History of Changes
Other Study ID Numbers: D4026C00001
Study First Received: March 18, 2008
Last Updated: March 24, 2009

Keywords provided by AstraZeneca:
High blood pressure
metoprolol succinate

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators processed this record on May 25, 2017