FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)
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ClinicalTrials.gov Identifier: NCT01071122 |
Recruitment Status
:
Completed
First Posted
: February 19, 2010
Last Update Posted
: January 27, 2014
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
Tracking Information | ||||
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First Submitted Date ICMJE | February 18, 2010 | |||
First Posted Date ICMJE | February 19, 2010 | |||
Last Update Posted Date | January 27, 2014 | |||
Study Start Date ICMJE | January 2010 | |||
Actual Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Central systolic blood pressure [ Time Frame: Week 8 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01071122 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry) | |||
Official Title ICMJE | A Prospective, Open-label, Active-controlled, Randomized Study Comparing Nifedipine GITS Versus Valsartan Versus a Combination of Both on Central Blood Pressure in Inadequately Controlled Essential Hypertension. | |||
Brief Summary | To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
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 * | Park JB, Shin JH, Kim DS, Youn HJ, Park SW, Shim WJ, Park CG, Kim DW, Lee HY, Choi DJ, Rim SJ, Lee SY, Kim JH; FOCUS Investigators. Safety of the Up-titration of Nifedipine GITS and Valsartan or Low-dose Combination in Uncontrolled Hypertension: the FOCUS Study. Clin Ther. 2016 Apr;38(4):832-42. doi: 10.1016/j.clinthera.2016.02.025. Epub 2016 Mar 17. | |||
* 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 |
365 | |||
Original Estimated Enrollment ICMJE |
356 | |||
Actual Study Completion Date | February 2012 | |||
Actual Primary Completion Date | February 2012 (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 | 20 Years to 70 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01071122 | |||
Other Study ID Numbers ICMJE | 14696 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bayer | |||
Study Sponsor ICMJE | Bayer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bayer | |||
Verification Date | January 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |