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A prospective, open, multicenter, non-interference real-world study evaluating the long-term safety of levamlodipine besylate tablets combined with bisoprolol fumarate tablets in hypertensive populations

A prospective, open, multicenter, non-interference real-world study evaluating the long-term safety of levamlodipine besylate tablets combined with bisoprolol fumarate tablets in hypertensive populations

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081144
Enrollment
Unknown
Registered
2024-02-23
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Group 1:1 tablet of levamlodipine besylate (2.5mg) and 1 tablet of bisoprolol fumarate (2.5mg), taken daily in the morning once a day for 26 weeks ± 2 weeks continuously
Group 2:1 tablet of levamlodipine besylate (2.5mg) and 1 tablet of bisoprolol fumarate (5mg), taken daily in the morning once a day for 26 weeks ± 2 weeks continuously

Sponsors

Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) According to the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Hypertension (revised in 2018), patients diagnosed with primary hypertension; (2) Currently receiving treatment with 2.5mg levamlodipine besylate tablets combined with 2.5mg bisoprolol fumarate tablets or 2.5mg levamlodipine besylate tablets combined with 5mg bisoprolol fumarate tablets; (3) Voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Known allergy to levamlodipine, amlodipine, and bisoprolol; (2) Pregnancy test positive, lactating women, or subjects with fertility plans during the study period; (3) Patients with known contraindications of levamlodipine, amlodipine, or bisoprolol, such as second or third degree atrioventricular block (without a pacemaker installed), sick sinus syndrome, sinus block, severe bronchial asthma, severe chronic obstructive pulmonary disease, advanced peripheral arterial obstructive disease, Raynaud's syndrome, untreated pheochromocytoma, metabolic acidosis, psoriasis, etc.

Countries

China

Contacts

Public ContactYan Shu

Sichuan Provincial People's Hospital

sichuanshuyan@163.com+86 28 8739 3999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026