Condition or disease | Intervention/treatment | Phase |
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Hypertension | Drug: SHR0532 Drug: SHR placebo Drug: Hydrochlorothiazide 25 mg | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Randomized, Double-Blind, Placebo-hydrochlorothiazide Parallel Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Efficacy of SHR 0532 Oral Tablets in Mild Hypertension Subjects |
Estimated Study Start Date : | June 2019 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |
Arm | Intervention/treatment |
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Experimental: SHR0532 tablet
up to 3 cohorts of subjects will receive multiple dose of oral tablets
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Drug: SHR0532
once daily(QD) for 4weeks
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Placebo Comparator: SHR0532 placebo
up to 3 cohorts of subjects will receive multiple dose of oral SHR0532 placebo
|
Drug: SHR placebo
once daily(QD) for 4weeks
|
Active Comparator: Hydrochlorothiazide
up to 3 cohorts of subjects will receive multiple dose of oral Hydrochlorothiazide 25mg
|
Drug: Hydrochlorothiazide 25 mg
once daily(QD) for 4weeks
|
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel diseases including ulcerative colitis, Crohn's disease, malabsorption syndrome, microbial dysbiosis, intestinal infection; History of gastrointestinal operations, such as gastric resection and bypass, small intestinal resection and colonic resection which may affect drug absorption
Taking or having the following medication history:
Any laboratory examination result meet the following criteria at screening/baseline:
Contact: Bo Zhu, Medical Director | +86-21-6105-3271 | zhubo@hrglobe.cn | |
Contact: Li jun Tang, Project Manager | +86 1870616501 | tanglijun@hrglobe.cn |
Tracking Information | |||||
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First Submitted Date ICMJE | May 28, 2019 | ||||
First Posted Date ICMJE | June 3, 2019 | ||||
Last Update Posted Date | June 3, 2019 | ||||
Estimated Study Start Date ICMJE | June 2019 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Adverse Events(AEs) and Serious Adverse Events (SAEs) [ Time Frame: from informed consent form signature to the end of the study (up to 2 months) ] Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolrability)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Effect Study of SHR0532 (Drug Code) Tablets in Patients With Mild Hypertension | ||||
Official Title ICMJE | A Phase I, Randomized, Double-Blind, Placebo-hydrochlorothiazide Parallel Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Efficacy of SHR 0532 Oral Tablets in Mild Hypertension Subjects | ||||
Brief Summary | The study is being conducted to evaluate the safety and efficacy and Pharmacokinetics/Pharmacodynamics of SHR0532 in subjects with mild hypertension for 4 weeks. | ||||
Detailed Description | This is a randomized, double-blind, multiple ascending dose, placebo- and Hydrochlorothiazide-controlled study to evaluate the safety and tolerability, Pharmacokinetics and Pharmacodynamics and effect on blood pressure of SHR0532 tablets in patients with mild hypertension. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
36 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2019 | ||||
Estimated Primary Completion Date | December 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
Gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel diseases including ulcerative colitis, Crohn's disease, malabsorption syndrome, microbial dysbiosis, intestinal infection; History of gastrointestinal operations, such as gastric resection and bypass, small intestinal resection and colonic resection which may affect drug absorption
Taking or having the following medication history:
Any laboratory examination result meet the following criteria at screening/baseline:
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Sex/Gender ICMJE |
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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 | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03971929 | ||||
Other Study ID Numbers ICMJE | SHR0532-102 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Jiangsu HengRui Medicine Co., Ltd. | ||||
Study Sponsor ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Jiangsu HengRui Medicine Co., Ltd. | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |