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

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

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.

Study Overview

• Status: Completed
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: nifedipine CR tablets (Xin Ran); Drug: nifedipine CR tablets (Adalat)

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: nifedipine CR tablets (Xin Ran); Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period.	Drug: nifedipine CR tablets (Xin Ran)
ACTIVE_COMPARATOR: nifedipine CR tablets (Adalat); Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period.	Drug: nifedipine CR tablets (Adalat)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in morning blood pressure surge from baseline	12 weeks
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
change in morning blood pressure from baseline	12 weeks
T/P ratio	12 weeks
average reduction in systolic blood pressure from 18 to 24 hours after administration	12 weeks
average reduction in diastolic blood pressure from 18 to 24 hours after administration	12 weeks
smoothness index	12 weeks
change in morning blood pressure surge from baseline	8 weeks
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline	8 weeks
change in morning blood pressure from baseline	8 weeks
T/P ratio	8 weeks
average reduction in systolic blood pressure from 18 to 24 hours after administration	8 weeks
average reduction in diastolic blood pressure from 18 to 24 hours after administration	8 weeks
smoothness index	8 weeks
change in systolic blood pressure (SBP) from baseline	12 weeks
change in diastolic blood pressure (DBP) from baseline	12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
clinical laboratory test and adverse event	12 weeks

Collaborators and Investigators

• Sponsor: Shanghai Shyndec Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Pingjin Gao, Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (ESTIMATE): January 9, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: CH-004PIV