Overview
This clinical study was designed to assess the safety and efficacy of long-term dosing of GW906
Description
This is an open-label, multicenter, non-randomized, long term extension study. Total study duration is expected to be up to 2 years, with a maximum of 3 years. Participants who have completed the previous GW906 Injection study will be assessed for eligibility at the screening visit of this study. Those who meet the eligibility criteria will receive the first dose of the extension treatment. Participants enrolled in this study will be preferentially assigned to Cohort 1. After enrollment into Cohort 2 has been initiated, participants will be assigned to receive treatment of the Cohort 2.
Eligibility
Inclusion Criteria:
- Completed study treatment and the study in accordance with the protocol for GW906 injection.
- Willing to participate in the study and provide written informed consent.
Exclusion Criteria:
- Secondary hypertension.
- Orthostatic hypotension accompanied by hypotension-related symptoms was observed in a prior study of GW906 injection.
- 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/1.73m\^2.
- History of any cardiovascular event within 6 months.
- Patients with active malignancy or a history of malignancy.
