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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

October 22, 2013
October 22, 2013
October 2013
October 2013   (final data collection date for primary outcome measure)
Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension
Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: Extended-Release Carvedilol Sulfate
  • Drug: Sustained-release Metoprolol Succinate
  • Experimental: Extended-Release Carvedilol Sulfate
    18-72mg/d,po
    Intervention: Drug: Extended-Release Carvedilol Sulfate
  • Active Comparator: Sustained-release Metoprolol Succinate
    47.5-190mg/d,po
    Intervention: Drug: Sustained-release Metoprolol Succinate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
302
Not Provided
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Yun Zhang, Professor 86 135731022060 yun-zhang@163.com
China
 
NCT01970059
KWDLEH2012
Yes
Jiangsu HengRui Medicine Co., Ltd.
Jiangsu HengRui Medicine Co., Ltd.
Not Provided
Principal Investigator: Yun Zhang, Professor Qilu Hospital
Jiangsu HengRui Medicine Co., Ltd.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP