About this trial
The purpose of this study is to evaluate the effect of GW906 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of GW906 as add-on therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years, of either sex.
Treated hypertension on stable therapy with up to 1 or 2 antihypertensive medications. Stable therapy is defined as having no change in antihypertensive medication or dose within 4 weeks prior to randomization.
Mean sitting systolic blood pressure (msSBP) ≥ 140 mmHg and < 180 mmHg at the randomization visit.
Willing to participate in the study and provide written informed consent.
Disqualifiers
Secondary hypertension.
orthostatic hypotension.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5× upper limit of normal (ULN); Total bilirubin > 1.5 × ULN; International normalized ratio (INR) > 2.0; Serum potassium > 5.0 mmol/L or < 3.5 mmol/L; eGFR≤30 mL/min/1.73m².
Received an investigational agent within the last 3 months.
Trial design
Parallel
Treatments tested in this trial
GW906
DrugSubcutaneous injection. 24 weeks
Placebo
DrugSubcutaneous injection. 24 weeks
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in mean sitting systolic blood pressure (msSBP) at Week 12
msSBP will be measured in the office using a validated sphygmomanometer, with the participant seated and resting quietly for at least 5 minutes. The primary endpoint is the change from baseline, calculated as the Week 12 value minus the baseline value, expressed in mmHg
Secondary outcomes
Change from baseline in mean sitting systolic blood pressure (msSBP) at Weeks 4, 8, and 24 of the double-blind period
Change from baseline, calculated as the Week 24 value minus the baseline value, expressed in mmHg
Sponsors and contacts
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