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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00642096

Purpose

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Metoprolol Metoprolol Tartrate Succinic acid Metoprolol succinate Metoprolol fumarate

U.S. FDA Resources

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 Hydrochlorothiazide	Drug: Hydrochlorothiazide

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642096

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Vasilios Papademetriou

Georgetown University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00642096 History of Changes
Other Study ID Numbers:	D4026C00001
Study First Received:	March 18, 2008
Last Updated:	March 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

High blood pressure
hypertension
(TOPROL-XL)
metoprolol succinate
hydrochlorothiazide

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Hydrochlorothiazide
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
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
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on February 09, 2012