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

March 24, 2009 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1900

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Metoprolol Succinate + Hydrochlorothiazide
Drug: Hydrochlorothiazide
Drug: Metoprolol Succinate
Other Names:
  • TOPROL-XL
Active Comparator: 2
Metoprolol Succinate
Drug: Metoprolol Succinate
Other Names:
  • TOPROL-XL
Active Comparator: 3
Hydrochlorothiazide
Drug: Hydrochlorothiazide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
change in trough Sitting Systolic Blood pressure
Time Frame: 3 readings determined at 8 weeks after treatment
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
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
6 readings determined at 8 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Vasilios Papademetriou, Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4026C00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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