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
1 other identifier
interventional
302
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hypertension
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedOctober 25, 2013
October 1, 2013
Same day
October 22, 2013
October 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8
Baseline and Week 8
Secondary Outcomes (2)
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8
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
Week 8
Study Arms (2)
Extended-Release Carvedilol Sulfate
EXPERIMENTAL18-72mg/d,po
Sustained-release Metoprolol Succinate
ACTIVE COMPARATOR47.5-190mg/d,po
Interventions
Eligibility Criteria
You may qualify if:
- Males or Females
- Aged from 18 to 70 years
- Had a history of essential hypertension
- Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Gansu Provincial Hospital
Lanzhou, Gansu, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Taizhou Hospital
Taizhou, Zhejiang, China
Xuan Wu hospital affiliated to Capital Medical University
Beijing, 100053, China
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, 11691777, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yun Zhang, Professor
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 25, 2013
Study Start
October 1, 2013
Primary Completion
October 1, 2013
Last Updated
October 25, 2013
Record last verified: 2013-10