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.
Overview
- Phase
- Phase 3
- Intervention
- Hydrochlorothiazide
- Conditions
- High Blood Pressure (Hypertension).
- Sponsor
- AstraZeneca
- Enrollment
- 1900
- Primary Endpoint
- Change in trough sitting diastolic blood pressure
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
3
Hydrochlorothiazide
Intervention: Hydrochlorothiazide
1
Metoprolol Succinate + Hydrochlorothiazide
Intervention: Metoprolol Succinate
1
Metoprolol Succinate + Hydrochlorothiazide
Intervention: Hydrochlorothiazide
2
Metoprolol Succinate
Intervention: Metoprolol Succinate
Outcomes
Primary Outcomes
Change in trough sitting diastolic blood pressure
Time Frame: 3 readings determined at 8 weeks after treatment
Secondary Outcomes
- change in trough Sitting Systolic Blood pressure(3 readings determined at 8 weeks after treatment)
- change in trough Standing Systolic Blood Pressure(6 readings determined at 8 weeks after treatment)
- change in trough standing diastolic blood pressure(6 readings determined at 8 weeks after treatment)