Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Shanghai Shyndec Pharmaceutical Co., Ltd.; Shanghai Shyndec Pharmaceutical Co.,Ltd.
• Treatments: Nifedipine

Criteria

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)

• Average DBP measured by 24-hour ambulatory blood pressure monitoring (ABPM) ≥80 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

• Uric acid >ULN with the diagnosis of gout

• 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

• Heavy smokers (>25 cigarettes every day), alcoholics (>250 ml liquor every day), drug addicts

• 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