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

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00642096 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

High Blood Pressure (Hypertension).

Intervention ^ICMJE

Drug: Metoprolol Succinate
Drug: Hydrochlorothiazide

Study Arms / Comparison Groups

Experimental: Metoprolol Succinate + Hydrochlorothiazide
Active Comparator: Metoprolol Succinate
Active Comparator: Hydrochlorothiazide

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1900

Completion Date

July 2004

Primary Completion Date

July 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00642096

Responsible Party

Study ID Numbers ^ICMJE

D4026C00001

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Vasilios Papademetriou

Georgetown University

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP