BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333) (EASE)
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ClinicalTrials.gov Identifier: NCT00546754 |
Recruitment Status
:
Completed
First Posted
: October 19, 2007
Results First Posted
: April 13, 2010
Last Update Posted
: May 5, 2017
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Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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Tracking Information | |||||
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First Submitted Date ICMJE | October 17, 2007 | ||||
First Posted Date ICMJE | October 19, 2007 | ||||
Results First Submitted Date | March 26, 2010 | ||||
Results First Posted Date | April 13, 2010 | ||||
Last Update Posted Date | May 5, 2017 | ||||
Actual Study Start Date ICMJE | May 1, 2007 | ||||
Actual Primary Completion Date | April 1, 2009 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Mean change reduction in SBP and DBP during 12 weeks of treatment with losartan 50 mg/HCTZ 12.5 mg titrated as needed versus valsartan 80 mg/HCTZ 12.5 mg titrated as needed [ Time Frame: 12 Weeks ] | ||||
Change History | Complete list of historical versions of study NCT00546754 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333) | ||||
Official Title ICMJE | BP-EASE-A 12-Week, Multicenter, Open-Label, Randomized, Controlled Trial To Compare The Effectiveness of Losartan 50 mg/HCTZ 12.5 mg Titrated as Needed to Losartan 100 mg/HCTZ 25 mg or Valsartan 160 mg/HCTZ 25 mg, in Patients With Essential Hypertension Who Have Not Achieved Target Blood Pressure With | ||||
Brief Summary | To evaluate the blood pressure efficacy between losartan and valsartan at equivalent dosage during a 3 months treatment. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Hypertension | ||||
Intervention ICMJE |
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Study Arms |
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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 | Completed | ||||
Actual Enrollment ICMJE |
808 | ||||
Original Estimated Enrollment ICMJE |
1000 | ||||
Actual Study Completion Date | May 1, 2009 | ||||
Actual Primary Completion Date | April 1, 2009 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 75 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00546754 | ||||
Other Study ID Numbers ICMJE | 0954A-333 MK0954A-333 2007_031 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Merck Sharp & Dohme Corp. | ||||
Study Sponsor ICMJE | Merck Sharp & Dohme Corp. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Merck Sharp & Dohme Corp. | ||||
Verification Date | March 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |