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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 244
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
    • Contact: Pingjin Gao

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)
• 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 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 8-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 8-week treatment period.	Drug: Adalat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
change in central systolic blood pressure from baseline .	8 weeks
change in central diastolic blood pressure from baseline .	8 weeks
change in central pulse pressure from baseline .	8 weeks
change in augmentation index from baseline .	8 weeks
change in mean systolic and diastolic pressure from baseline	8 weeks

Collaborators and Investigators

• Sponsor: Shanghai Shyndec Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2015
• Study Completion (ANTICIPATED): September 1, 2015

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (ESTIMATE): February 6, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: December 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 -2