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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
First received: October 22, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
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
Drug: Extended-Release Carvedilol Sulfate
Drug: Sustained-release Metoprolol Succinate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Secondary Outcome Measures:
  • Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8 [ Time Frame: Baseline and Week 8 ]
  • 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 ]

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
Drug: Extended-Release Carvedilol Sulfate
Active Comparator: Sustained-release Metoprolol Succinate
Drug: Sustained-release Metoprolol Succinate


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Anti-Arrhythmia Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on January 23, 2017