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

Primary Purpose

Essential Hypertension

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
nifedipine CR tablets (Xin Ran)
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)
  • 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

Sites / Locations

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical SchoolRecruiting

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 8-week treatment period.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change in central systolic blood pressure from baseline .
change in central diastolic blood pressure from baseline .
change in central pulse pressure from baseline .
change in augmentation index from baseline .
change in mean systolic and diastolic pressure from baseline

Full Information

First Posted
January 30, 2015
Last Updated
February 3, 2015
Sponsor
Shanghai Shyndec Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02357615
Brief Title
Efficacy Study of Nifedipine Controlled-Release Tablets (Xin Ran) to Treat Early Morning Blood Pressure and Central Arterial Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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 Early Morning Blood Pressure and Central Arterial Pressure.

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
244 (Anticipated)

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 8-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 8-week treatment period.
Intervention Type
Drug
Intervention Name(s)
nifedipine CR tablets (Xin Ran)
Intervention Type
Drug
Intervention Name(s)
Adalat
Primary Outcome Measure Information:
Title
change in the average of early morning blood pressure mean systolic and diastolic pressure from baseline
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
change in central systolic blood pressure from baseline .
Time Frame
8 weeks
Title
change in central diastolic blood pressure from baseline .
Time Frame
8 weeks
Title
change in central pulse pressure from baseline .
Time Frame
8 weeks
Title
change in augmentation index from baseline .
Time Frame
8 weeks
Title
change in mean systolic and diastolic pressure from baseline
Time Frame
8 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chongping Liu
Phone
(86)21-62102186
Facility Information:
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiao Tong University Medical School
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pingjin Gao

12. IPD Sharing Statement

Learn more about this trial

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

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