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A real-world study on the generic drug of nifedipine controlled-release tablets and the original drug (Bystolic)

A multicenter, retrospective, real-world clinical study evaluating the efficacy and safety of nifedipine controlled-release tablet generic drugs versus the original drug (Bystolic) in the treatment of patients with essential hypertension.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125103
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-05-29
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

This study will collect patients with essential hypertension who have taken nifedipine controlled-release tablets, either generic or originator drugs, from August 1, 2023, to July 31, 2025.

Interventions

generic drug of nifedipine controlled-release tablets:None
Nifedipine controlled-release tablet original drug (Nifedipine GITS):None

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 100 Years

Inclusion criteria

Inclusion criteria: During the identification period, there is at least one prescription record for generic or originator nifedipine controlled-release tablets.

Exclusion criteria

Exclusion criteria: 1. Patients without outpatient or inpatient visit records after enrollment; 2. Patients with abnormal daily dosage (exceeding the dosage specified in the drug instructions); 3. Patients with poor compliance to nifedipine controlled-release tablets during the follow-up period (medication compliance is considered low if the number of days covered by medication is less than 80%); 4. Patients without blood pressure measurement results during the follow-up period.

Design outcomes

Primary

MeasureTime frame
Blood pressure control rate after taking nifedipine controlled-release tablets, either generic or originator drugs, for 12 weeks.;—

Secondary

MeasureTime frame
The total incidence of adverse drug reactions (ADR) within 1 year after 12 weeks of continuous use of generic or originator nifedipine controlled-release tablets;;The rate of drug discontinuation due to adverse events during the follow-up period.;Dose adjustment rate of antihypertensive drugs;;Glomerular filtration rate (GFR) changes;Incidence of serious adverse events (SAE) during the follow-up period;;Blood pressure control rate after taking nifedipine controlled-release tablets, either generic or original brand, for 4 or 8 weeks;;The proportion of patients who required an increase in dosage, combination therapy, or a change to other antihypertensive drugs due to unmet blood pressure targets during follow-up;The fluctuation range (standard deviation) of blood pressure (SBP/DBP) after taking nifedipine controlled-release tablets, either generic or originator drugs, for 4, 8, and 12 weeks;;—

Countries

China

Contacts

Public ContactLiao Xiaoyang

West China Hospital, Sichuan University

liaoxiaoyang@wchscu.cn+86 28 8542 1550

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026