Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Early Morning Blood Pressure and Central Arterial Pressure

Essential Hypertension Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02357615
• Other study ID #: CH-004PIV -2
• Status: Recruiting
• Phase: Phase 4
• First received: January 30, 2015
• Last updated: February 3, 2015
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2014
• Source: Shanghai Shyndec Pharmaceutical Co.,Ltd.
• Contact: Chongping Liu
• Phone: (86)21-62102186
• 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 Early Morning Blood Pressure and Central Arterial Pressure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• 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)

• The mean morning blood press of one week >135/85 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

• 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

• 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)

• Adalat

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School	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
Primary	change in the average of early morning blood pressure mean systolic and diastolic pressure from baseline	early morning blood pressure mean systolic and diastolic pressure measured by Omron-7080-IC calculated as the mean of all of the early morning blood pressure mean systolic and diastolic pressure measurements for 7 consecutive days after 8 weeks.	8 weeks	No
Secondary	change in central systolic blood pressure from baseline .		8 weeks	No
Secondary	change in central diastolic blood pressure from baseline .		8 weeks	No
Secondary	change in central pulse pressure from baseline .		8 weeks	No
Secondary	change in augmentation index from baseline .		8 weeks	No
Secondary	change in mean systolic and diastolic pressure from baseline		8 weeks	No