Clinical trial NCT01970059: A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension
Official title: Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8
timeFrame: Baseline and Week 8
measure: Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Gansu Provincial Hospital
state: Gansu
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Taizhou
country: China
facility: Taizhou Hospital
state: Zhejiang
city: Beijing
country: China
facility: Xuan Wu hospital affiliated to Capital Medical University
city: Beijing
country: China
facility: Beijing Tongren hospital affiliated to Capital Medical University
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yun Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: