| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
Experimental: SHR0532 tablet
up to 3 cohorts of subjects will receive multiple dose of oral tablets
|
Drug: SHR0532
once daily(QD) for 4weeks
|
|
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 | |||||
|---|---|---|---|---|---|
| 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 | ||||
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* 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 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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