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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
nifedipine CR tablets (Xin Ran)
nifedipine CR tablets (Adalat)
Sponsored by
Shanghai Shyndec Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nifedipine CR tablets (Xin Ran)

nifedipine CR tablets (Adalat)

Arm Description

Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period.

Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period.

Outcomes

Primary Outcome Measures

change in morning blood pressure surge from baseline
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2014
Last Updated
February 3, 2015
Sponsor
Shanghai Shyndec Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02031861
Brief Title
Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Mild to Moderate Essential Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Shyndec Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 mild to moderate essential hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nifedipine CR tablets (Xin Ran)
Arm Type
Experimental
Arm Description
Subjects will take a nifedipine controlled-release tablet (30 mg, Xin Ran) orally in every morning for a 12-week treatment period.
Arm Title
nifedipine CR tablets (Adalat)
Arm Type
Active Comparator
Arm Description
Subjects will take a nifedipine controlled-release tablet (30 mg, Adalat) orally in every morning for a 12-week treatment period.
Intervention Type
Drug
Intervention Name(s)
nifedipine CR tablets (Xin Ran)
Intervention Type
Drug
Intervention Name(s)
nifedipine CR tablets (Adalat)
Primary Outcome Measure Information:
Title
change in morning blood pressure surge from baseline
Time Frame
12 weeks
Title
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change in morning blood pressure from baseline
Time Frame
12 weeks
Title
T/P ratio
Time Frame
12 weeks
Title
average reduction in systolic blood pressure from 18 to 24 hours after administration
Time Frame
12 weeks
Title
average reduction in diastolic blood pressure from 18 to 24 hours after administration
Time Frame
12 weeks
Title
smoothness index
Time Frame
12 weeks
Title
change in morning blood pressure surge from baseline
Time Frame
8 weeks
Title
change in central systolic blood pressure, central diastolic blood pressure, central pulse pressure and augmentation index from baseline
Time Frame
8 weeks
Title
change in morning blood pressure from baseline
Time Frame
8 weeks
Title
T/P ratio
Time Frame
8 weeks
Title
average reduction in systolic blood pressure from 18 to 24 hours after administration
Time Frame
8 weeks
Title
average reduction in diastolic blood pressure from 18 to 24 hours after administration
Time Frame
8 weeks
Title
smoothness index
Time Frame
8 weeks
Title
change in systolic blood pressure (SBP) from baseline
Time Frame
12 weeks
Title
change in diastolic blood pressure (DBP) from baseline
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
clinical laboratory test and adverse event
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pingjin Gao
Organizational Affiliation
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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