A Phase 2 interventional study of CS-3150 in Hypertension, sponsored by Daiichi Sankyo. Completed at 1 site in Japan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Daiichi Sankyo · Phase 2, Interventional, and Treatment
This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 33 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Daiichi Sankyo is the lead sponsor of 322 studies on the registry; 37 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
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Exclusion Criteria:
CS-3150 1.25 to 5.0 mg , orally, once daily after breakfast for 12 weeks
Drug: CS-3150
Change from baseline in sitting systolic and diastolic blood pressure
Time frame: Baseline to end of Week 12
Change from baseline in UACR
Urine Albumin Creatinine Ratio (UACR)
Time frame: Baseline to end of Week 12
Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
The record gives a start of May 2015, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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