Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Early Morning Blood Pressure and Central Arterial Pressure
Phase 4
- Conditions
- Essential Hypertension
- Interventions
- Registration Number
- NCT02357615
- Lead Sponsor
- Shanghai Shyndec Pharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to compare nifedipine controlled-release (CR) tablets (Xin Ran) with nifedipine controlled-release tablets (Adalat）in the treatment of Early Morning Blood Pressure and Central Arterial Pressure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 244
Inclusion Criteria
- Voluntarily participate and must sign informed consent form
- Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
- The mean morning blood press of one week >135/85 mmHg
Exclusion Criteria
- Secondary hypertension and malignant hypertension
- Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
- Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
- Have following complications: cerebrovascular accident within 6 months, myocardial infarction or cardiac failure, macroaneurysm or dissecting aneurysm, definite angina, A-V block of grade 2 or higher, sick sinus syndrome, atrial fibrillation or other malignant arrhythmia
- Clinical significant diseases of heart, lung, liver, kidney and hematologic system or malignant tumors, HIV infection, uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥7.8 mmol/L)
- Kock pouch
- Sever gastrointestinal stenosis
- Abnormal laboratory values with clinical significance, including serum potassium <3.5 or >5.5 mmol/L, glutamic-pyruvic transaminase (ALT) or glutamic oxalacetic transaminase (AST) >2-fold upper limit of normal (ULN), Cr >ULN
- Gastrointestinal abnormalities or surgery that may interfere with drug absorption
- Hyperthyroidism or hypothyroidism
- Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
- Psychological diseases, acrasia, cannot express explicitly
- Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
- Anxiety disorders, depression or cannot follow study protocol
- BMI >30
- Night shift, irregular sleep patterns or insomnia
- participate in other clinical trials within 3 months
- other conditions that investigators consider unsuitable for participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nifedipine CR tablets (Xin Ran) nifedipine CR tablets (Xin Ran) Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 8-week treatment period. nifedipine CR tablets (Adalat) Adalat Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 8-week treatment period.
- Primary Outcome Measures
Name Time Method change in the average of early morning blood pressure mean systolic and diastolic pressure from baseline 8 weeks early morning blood pressure mean systolic and diastolic pressure measured by Omron-7080-IC calculated as the mean of all of the early morning blood pressure mean systolic and diastolic pressure measurements for 7 consecutive days after 8 weeks.
- Secondary Outcome Measures
Name Time Method change in central diastolic blood pressure from baseline . 8 weeks change in mean systolic and diastolic pressure from baseline 8 weeks change in central systolic blood pressure from baseline . 8 weeks change in central pulse pressure from baseline . 8 weeks change in augmentation index from baseline . 8 weeks
Trial Locations
- Locations (1)
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
🇨🇳Shanghai, China