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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031861
• Other study ID #: CH-004PIV
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2014
• Last updated: February 3, 2015
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: April 2014
• Source: Shanghai Shyndec Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• nifedipine CR tablets (Xin Ran)

• nifedipine CR tablets (Adalat)

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Shyndec Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	clinical laboratory test and adverse event		12 weeks	Yes
Primary	change in morning blood pressure surge from baseline		12 weeks	No
Primary	change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline		12 weeks	No
Secondary	change in morning blood pressure from baseline		12 weeks	No
Secondary	T/P ratio		12 weeks	No
Secondary	average reduction in systolic blood pressure from 18 to 24 hours after administration		12 weeks	No
Secondary	average reduction in diastolic blood pressure from 18 to 24 hours after administration		12 weeks	No
Secondary	smoothness index		12 weeks	No
Secondary	change in morning blood pressure surge from baseline		8 weeks	No
Secondary	change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline		8 weeks	No
Secondary	change in morning blood pressure from baseline		8 weeks	No
Secondary	T/P ratio		8 weeks	No
Secondary	average reduction in systolic blood pressure from 18 to 24 hours after administration		8 weeks	No
Secondary	average reduction in diastolic blood pressure from 18 to 24 hours after administration		8 weeks	No
Secondary	smoothness index		8 weeks	No
Secondary	change in systolic blood pressure (SBP) from baseline		12 weeks	No
Secondary	change in diastolic blood pressure (DBP) from baseline		12 weeks	No