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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00642096
First received: March 18, 2008
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  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 3

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:

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 June 18, 2013