Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension
Study Details
Study Description
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 mild to moderate essential hypertension.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: nifedipine CR tablets (Xin Ran) Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period. |
Drug: nifedipine CR tablets (Xin Ran)
|
| Active Comparator: nifedipine CR tablets (Adalat) Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period. |
Drug: nifedipine CR tablets (Adalat)
|
Outcome Measures
Primary Outcome Measures
- change in morning blood pressure surge from baseline [12 weeks]
- change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline [12 weeks]
Secondary Outcome Measures
- change in morning blood pressure from baseline [12 weeks]
- T/P ratio [12 weeks]
- average reduction in systolic blood pressure from 18 to 24 hours after administration [12 weeks]
- average reduction in diastolic blood pressure from 18 to 24 hours after administration [12 weeks]
- smoothness index [12 weeks]
- change in morning blood pressure surge from baseline [8 weeks]
- change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline [8 weeks]
- change in morning blood pressure from baseline [8 weeks]
- T/P ratio [8 weeks]
- average reduction in systolic blood pressure from 18 to 24 hours after administration [8 weeks]
- average reduction in diastolic blood pressure from 18 to 24 hours after administration [8 weeks]
- smoothness index [8 weeks]
- change in systolic blood pressure (SBP) from baseline [12 weeks]
- change in diastolic blood pressure (DBP) from baseline [12 weeks]
Other Outcome Measures
- clinical laboratory test and adverse event [12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntarily participate and must sign informed consent form
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Mild to moderate essential hypertension (SBP 140-179 mmHg and/or DBP 90-109 mmHg)
-
Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 mmHg
Exclusion Criteria:
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Secondary hypertension and malignant hypertension
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Pregnant or nursing women, or patients that cannot guarantee to take effective contraception measures
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Baseline SBP≥180 mmHg or DBP≥110 mmHg, or patients with cerebral, cardiac or renal complications
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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
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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)
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Kock pouch
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Sever gastrointestinal stenosis
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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
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Uric acid >ULN with the diagnosis of gout
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Gastrointestinal abnormalities or surgery that may interfere with drug absorption
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Hyperthyroidism or hypothyroidism
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Allergic to any ingredient or metabolite of investigational drug or drugs of similar structure
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Heavy smokers (>25 cigarettes every day), alcoholics (>250 ml liquor every day), drug addicts
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Psychological diseases, acrasia, cannot express explicitly
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Patients whose mood may be affected by variations in blood pressure, which in turn increases blood pressure
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Anxiety disorders, depression or cannot follow study protocol
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BMI >30
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Night shift, irregular sleep patterns or insomnia
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participate in other clinical trials within 3 months
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other conditions that investigators consider unsuitable for participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Shanghai Shyndec Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Pingjin Gao, Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CH-004PIV