Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open-label, observational study. The aim of this study is to evaluate the efficacy of Nifedipine GITS on lowering blood pressure in Chinese adults with mild-to-moderate hypertension.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborator: Bayer
• Treatments: Nifedipine

Criteria

Inclusion Criteria:

• a seated systolic BP (SBP) ≥140 mmHg and <180 mmHg and/or a seated diastolic BP (DBP) ≥90 mmHg and <110 mmHg;

• an age ≥18 and ≤75 years;

• those who had not taken any BP-lowering medications in 1 month before the study.

Exclusion Criteria:

• a seated systolic BP (SBP) ≥180 mmHg and/or a seated diastolic BP ≥110 mmHg;

• secondary hypertension;

• diagnosed heart failure or stroke;

• Any of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was above 1.5 times of it's normal value upper limit, Serum creatinine >177 µmmol/L (2mg/dL), or liver cirrhosis;

• subjects with carotid stenosis or systolic murmur

• subjects with a history of unstable angina pectoris, acute mycardial infarction, percutaneous transluminal coronary angiography or coronary artery bypass grafting in the past 6 months;

• subjects who were within lactation period, pregnant, or planning to become pregnant during the study;

• hypersensitive to Nifedipine GITS or with SAE;

• subjects who are participating in other clinical trials;

• considered not fit for the study due to other reasons according to the researchers (such as Malignant tumor, psyche or nervous system dysfunction, or special diseases).