Clinical trial NCT02031861: Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension
Official title: Random, Open Label, Active Comparator-controlled Parallel Study to Evaluate the Efficacy of Nifedipine Controlled-released Tablets (Xin Ran) in Patients With Mild to Moderate Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Lead sponsor: Shanghai Shyndec Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: change in morning blood pressure surge from baseline
timeFrame: 12 weeks
measure: change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: change in morning blood pressure from baseline
timeFrame: 12 weeks
measure: T/P ratio
timeFrame: 12 weeks
measure: average reduction in systolic blood pressure from 18 to 24 hours after administration
timeFrame: 12 weeks
measure: average reduction in diastolic blood pressure from 18 to 24 hours after administration
timeFrame: 12 weeks
measure: smoothness index
timeFrame: 12 weeks
measure: change in morning blood pressure surge from baseline
timeFrame: 8 weeks
measure: change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
timeFrame: 8 weeks
measure: change in morning blood pressure from baseline
timeFrame: 8 weeks
measure: T/P ratio
timeFrame: 8 weeks
measure: average reduction in systolic blood pressure from 18 to 24 hours after administration
timeFrame: 8 weeks
measure: average reduction in diastolic blood pressure from 18 to 24 hours after administration
timeFrame: 8 weeks
measure: smoothness index
timeFrame: 8 weeks
measure: change in systolic blood pressure (SBP) from baseline
timeFrame: 12 weeks
measure: change in diastolic blood pressure (DBP) from baseline
timeFrame: 12 weeks
Other outcomes:
measure: clinical laboratory test and adverse event
timeFrame: 12 weeks
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
name: Pingjin Gao
role: PRINCIPAL_INVESTIGATOR
References: