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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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