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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Jiangsu HengRui Medicine Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01970059
First received: October 22, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Extended-Release Carvedilol Sulfate
Drug: Sustained-release Metoprolol Succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Jiangsu HengRui Medicine Co., Ltd.:

Primary Outcome Measures:
  • Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 302
Study Start Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended-Release Carvedilol Sulfate
18-72mg/d,po
Drug: Extended-Release Carvedilol Sulfate
Active Comparator: Sustained-release Metoprolol Succinate
47.5-190mg/d,po
Drug: Sustained-release Metoprolol Succinate

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970059

Contacts
Contact: Yun Zhang, Professor 86 135731022060 yun-zhang@163.com

Locations
China, Gansu
Gansu Provincial Hospital Recruiting
Lanzhou, Gansu, China
China, Hebei
The Fourth Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China
China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China
China, Jiangsu
The Second Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital Recruiting
Yangzhou, Jiangsu, China, 225001
China, Liaoning
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yun Zhang, Professor    86 135731022060    yun-zhang@163.com   
Principal Investigator: Yun Zhang, Professor         
China, Zhejiang
Taizhou Hospital Recruiting
Taizhou, Zhejiang, China
China
Xuan Wu hospital affiliated to Capital Medical University Recruiting
Beijing, China, 100053
Beijing Tongren hospital affiliated to Capital Medical University Recruiting
Beijing, China, 11691777
Longhua Hospital Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Principal Investigator: Yun Zhang, Professor Qilu Hospital
  More Information

No publications provided

Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01970059     History of Changes
Other Study ID Numbers: KWDLEH2012
Study First Received: October 22, 2013
Last Updated: October 22, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Carvedilol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists

ClinicalTrials.gov processed this record on September 30, 2014