High Blood Pressure (Hypertension).
Conditions
Keywords
High blood pressure, hypertension, (TOPROL-XL), metoprolol succinate, hydrochlorothiazide
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.
Interventions
DRUGMetoprolol Succinate
DRUGHydrochlorothiazide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in trough sitting diastolic blood pressure | 3 readings determined at 8 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed