Overview

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