Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension (NCT02641821) | Clinical Trial Compass
UnknownPhase 4
Effect of Nifedipine GITS in Patients With Mild-to-moderate Primary Hypertension
China700 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
What they're measuring
1
Control rate of hypertension evaluated by office blood pressure at 8 weeks
Timeframe: 8 weeks
2
Control rate of hypertension evaluated by office blood pressure at 4 weeks
Timeframe: 4 weeks
3
Control rate of hypertension evaluated by office blood pressure at 2 weeks