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

NCT ID: NCT02357615

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-09-30

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 Early Morning Blood Pressure and Central Arterial Pressure.

Conditions

Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nifedipine CR tablets (Xin Ran)

Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 8-week treatment period.

Group Type: EXPERIMENTAL

nifedipine CR tablets (Xin Ran)

Intervention Type: DRUG

nifedipine CR tablets (Adalat)

Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 8-week treatment period.

Group Type: ACTIVE_COMPARATOR

Adalat

Intervention Type: DRUG

Interventions

nifedipine CR tablets (Xin Ran)

Intervention Type: DRUG

Adalat

Intervention Type: DRUG

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Shyndec Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chongping Liu

Role: CONTACT

(86)21-62102186

Facility Contacts

Pingjin Gao

Role: primary

Other Identifiers

CH-004PIV -2

Identifier Type: -

Identifier Source: org_study_id