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A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Extended-Release Carvedilol Sulfate
Sustained-release Metoprolol Succinate
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • Males or Females
  • Aged from 18 to 70 years
  • Had a history of essential hypertension
  • Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg

Exclusion Criteria:

  • Malignant hypertension
  • Average sitting systolic blood pressure≧180mmHg
  • Type 2 diabetes with hemoglobin A1c≥9%
  • Type 1 diabetes
  • New York Heart Association class Ⅱ-Ⅳ congestive heart-failure
  • Unstable angina
  • Second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place
  • Atrial fibrillation
  • Bradycardia (<60 bpm, seated)
  • Asthma or other obstructive pulmonary disease
  • History of myocardial infarction
  • Stroke in the 6 months before screening
  • Known contraindications to β-adrenergic blocker therapy
  • Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>3 times upper limit of normal
  • Crea>2 times upper limit of normal
  • Pregnancy or lactation

Sites / Locations

  • Gansu Provincial HospitalRecruiting
  • The Fourth Hospital of Hebei Medical UniversityRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • The Second Affiliated Hospital of Soochow UniversityRecruiting
  • Northern Jiangsu People's HospitalRecruiting
  • Shengjing Hospital of China Medical UniversityRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Taizhou HospitalRecruiting
  • Xuan Wu hospital affiliated to Capital Medical UniversityRecruiting
  • Beijing Tongren hospital affiliated to Capital Medical UniversityRecruiting
  • Longhua Hospital Shanghai University of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extended-Release Carvedilol Sulfate

Sustained-release Metoprolol Succinate

Arm Description

18-72mg/d,po

47.5-190mg/d,po

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8

Secondary Outcome Measures

Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8
Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8

Full Information

First Posted
October 22, 2013
Last Updated
October 22, 2013
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01970059
Brief Title
A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension
Official Title
Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extended-Release Carvedilol Sulfate
Arm Type
Experimental
Arm Description
18-72mg/d,po
Arm Title
Sustained-release Metoprolol Succinate
Arm Type
Active Comparator
Arm Description
47.5-190mg/d,po
Intervention Type
Drug
Intervention Name(s)
Extended-Release Carvedilol Sulfate
Intervention Type
Drug
Intervention Name(s)
Sustained-release Metoprolol Succinate
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8
Time Frame
Baseline and Week 8
Title
Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8
Time Frame
Week 8

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: Males or Females Aged from 18 to 70 years Had a history of essential hypertension Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg Exclusion Criteria: Malignant hypertension Average sitting systolic blood pressure≧180mmHg Type 2 diabetes with hemoglobin A1c≥9% Type 1 diabetes New York Heart Association class Ⅱ-Ⅳ congestive heart-failure Unstable angina Second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place Atrial fibrillation Bradycardia (<60 bpm, seated) Asthma or other obstructive pulmonary disease History of myocardial infarction Stroke in the 6 months before screening Known contraindications to β-adrenergic blocker therapy Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>3 times upper limit of normal Crea>2 times upper limit of normal Pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun Zhang, Professor
Phone
86 135731022060
Email
yun-zhang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun Zhang, Professor
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gansu Provincial Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Zhang, Professor
Phone
86 135731022060
Email
yun-zhang@163.com
First Name & Middle Initial & Last Name & Degree
Yun Zhang, Professor
Facility Name
Taizhou Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Xuan Wu hospital affiliated to Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Tongren hospital affiliated to Capital Medical University
City
Beijing
ZIP/Postal Code
11691777
Country
China
Individual Site Status
Recruiting
Facility Name
Longhua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension

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