Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate (ESAHOM)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02612298 |
Recruitment Status :
Completed
First Posted : November 23, 2015
Last Update Posted : April 17, 2019
|
Sponsor:
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Information provided by (Responsible Party):
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | September 2, 2015 | |||
First Posted Date ICMJE | November 23, 2015 | |||
Last Update Posted Date | April 17, 2019 | |||
Actual Study Start Date ICMJE | August 2015 | |||
Actual Primary Completion Date | September 13, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Diastolic blood pressure [ Time Frame: 12 weeks ] Changes in diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) after treatment
|
|||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures |
Safety assessed by incidence rate of adverse events [ Time Frame: 12 weeks ] | |||
Original Other Pre-specified Outcome Measures | Same as current | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate | |||
Official Title ICMJE | Efficacy and Safety of Arotinolol Hydrochloride on Morning Blood Pressure and Heart Rate in Patients With Essential Hypertension | |||
Brief Summary | The purpose of this study is to compare the efficacy and safety of Arotinolol Hydrochloride and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in patients with essential hypertension. To provide evidence for hypertension treatment. A group: Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks. B group: Metoprolol succinate sustained-release tablet, oral, 23.75-71.25mg, qd for 12 weeks. |
|||
Detailed Description | Compare the efficacy and safety of Arotinolol Hydrochloride and Metoprolol succinate on morning blood pressure, heart rate and target organ damage in patients with essential hypertension. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Essential Hypertension | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
198 | |||
Original Estimated Enrollment ICMJE |
200 | |||
Actual Study Completion Date ICMJE | September 13, 2018 | |||
Actual Primary Completion Date | September 13, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02612298 | |||
Other Study ID Numbers ICMJE | DSPC-ALM-1401 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Sumitomo Pharmaceutical (Suzhou) Co., Ltd. | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Sumitomo Pharmaceutical (Suzhou) Co., Ltd. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Sumitomo Pharmaceutical (Suzhou) Co., Ltd. | |||
Verification Date | April 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |