Multicenter observational study of efficacy and safety of enalapril maleate folate tablets/amlodipine besylate folate tablets in patients with type 2 diabetes and hypertension

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200063451

Enrollment

Unknown

Registered

2022-09-07

Start date

2022-09-01

Completion date

Unknown

Last updated

2023-04-17

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

Conditions

hypertension

Interventions

Case series:None

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, no gender limitation; 2. It also met the diagnostic criteria of type 2 diabetes in "China Guidelines for Prevention and Treatment of Type 2 Diabetes (2020 edition)" and essential hypertension in "China Guidelines for Prevention and Treatment of Hypertension (2018 Revised Edition)"; 3. 140 mmHg < SBP < 180 mmHg, 90 mmHg < DBP < 110 mmHg; 4. The patients voluntarily participated in the examination and agreed to sign the informed consent; 5. Did not participate in other clinical drug trials within 12 weeks; 6. It is expected to live in Shenzhen for more than 1 year after inclusion in the trial.

Exclusion criteria

Exclusion criteria: 1. Cardiac insufficiency (New York College of Cardiology Grade II, III, IV); 2. Renal insufficiency (creatinine > 200 umol/L); 3. Abnormal liver function (alanine aminotransferase and aspartate aminotransferase are more than 2 times higher than normal limit); 4. Complicated with acute complications of diabetes, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma or lactic acidosis; 5. Patients with complicated tumor, past history of heart and brain disease and serious diseases such as heart, brain and kidney; 6. Pregnancy and planned pregnancy within 6 months of the patient, breast-feeding women; 7. Patients with cognitive impairment and severe mental disorders who cannot express themselves normally and cannot cooperate to complete the examination; 8. Patients who are taking folic acid or other B vitamins or compound preparations containing folic acid; 9. Missing rate > 15% due to incomplete data.

Design outcomes

Primary

Measure	Time frame
Hcy;Blood folic acid;	—

Secondary

Measure	Time frame
Blood press;Fasting plasma glucose;HbA1c;	—

Countries

China

Contacts

Public ContactJianlong Wu

Shenzhen Second People's Hospital

wjl06@163.com+86 13802555718

Outcome results

None listed

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