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Trial record 3 of 134 for:    OLMESARTAN

Study of CS-3150 Compared to Olmesartan in Patients With Essential Hypertension

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ClinicalTrials.gov Identifier: NCT02848170
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: CS-3150 Drug: olmesartan medoxomil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension
Study Start Date : August 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CS-3150
CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks
Drug: CS-3150
CS-3150 2.5mg, oral

Active Comparator: olmesartan medoxomil
olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks
Drug: olmesartan medoxomil
olmesartan medoxomil 10 mg, oral
Other Name: Benicar




Primary Outcome Measures :
  1. Change from baseline in 24 hr blood pressure [ Time Frame: baseline to end of Week 12 ]
    Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12


Secondary Outcome Measures :
  1. Change from baseline in morning, evening, and night blood pressure. [ Time Frame: baseline to week 12 ]
    Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.

  2. Change from baseline in sitting blood pressure [ Time Frame: baseline to week 12 ]
    Relationship between the change from baseline in sitting blood pressure (systolic, diastolic, and average blood pressure) and baseline factors.

  3. Time course of 24 hr blood pressure and sitting blood pressure [ Time Frame: week 12 ]
    Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and average blood pressure)

  4. Proportion of patients achieving 24 hr and sitting blood pressure control [ Time Frame: week 12 ]
    Proportion of patients achieving 24 hr and sitting blood pressure control



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged 20 years or older at informed consent
  • Subjects with essential hypertension during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and < 110 mmHg)

Exclusion Criteria:

  • Secondary hypertension or malignant hypertension
  • Diabetes mellitus with albuminuria
  • Serum potassium level < 3.5 or ≥ 5.1 milliequivalent (mEq)/L
  • Reversed day-night life cycle including overnight workers
  • estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848170


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02848170     History of Changes
Other Study ID Numbers: CS3150-A-J303
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
essential hypertension
mineralocorticoid receptor antagonist
Developmental Phase III
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action