A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT01970059
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 302
- Males or Females
- Aged from 18 to 70 years
- Had a history of essential hypertension
- Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended-Release Carvedilol Sulfate Extended-Release Carvedilol Sulfate 18-72mg/d,po Sustained-release Metoprolol Succinate Sustained-release Metoprolol Succinate 47.5-190mg/d,po
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8 Baseline and Week 8
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (11)
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Beijing Tongren hospital affiliated to Capital Medical University
🇨🇳Beijing, China
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Taizhou Hospital
🇨🇳Taizhou, Zhejiang, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Xuan Wu hospital affiliated to Capital Medical University
🇨🇳Beijing, China