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Completed

NCT Number: NCT00642096

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

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.

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Key information

Conditions

High Blood Pressure (Hypertension). Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metoprolol succinate

Drug

Other names: TOPROL-XL

Hydrochlorothiazide

Drug

Primary outcomes

  1. Change in trough sitting diastolic blood pressure

    Time frame: 3 readings determined at 8 weeks after treatment

Secondary outcomes

  1. change in trough Sitting Systolic Blood pressure

    Time frame: 3 readings determined at 8 weeks after treatment

  2. change in trough Standing Systolic Blood Pressure

    Time frame: 6 readings determined at 8 weeks after treatment

  3. change in trough standing diastolic blood pressure

    Time frame: 6 readings determined at 8 weeks after treatment

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 24, 2008
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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