A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension
NCT ID: NCT01970059
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
302 participants
INTERVENTIONAL
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Extended-Release Carvedilol Sulfate
18-72mg/d,po
Extended-Release Carvedilol Sulfate
Sustained-release Metoprolol Succinate
47.5-190mg/d,po
Sustained-release Metoprolol Succinate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Extended-Release Carvedilol Sulfate
Sustained-release Metoprolol Succinate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged from 18 to 70 years
* Had a history of essential hypertension
* Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yun Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital of Shandong University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Taizhou Hospital
Taizhou, Zhejiang, China
Xuan Wu hospital affiliated to Capital Medical University
Beijing, , China
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, , China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yun Zhang, Professor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KWDLEH2012
Identifier Type: -
Identifier Source: org_study_id