FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)
NCT ID: NCT01071122
Last Updated: 2014-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
365 participants
INTERVENTIONAL
2010-01-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Nifedipine (Adalat, BAYA1040) and Valsartan
Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
Arm 2
Nifedipine (Adalat, BAYA1040)
Nifedipine 60mg, Once daily
Arm 3
Valsartan
Valsartan 160mg, Once daily
Interventions
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Nifedipine (Adalat, BAYA1040) and Valsartan
Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
Nifedipine (Adalat, BAYA1040)
Nifedipine 60mg, Once daily
Valsartan
Valsartan 160mg, Once daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Mean systolic BP \>/= 200mmHg and or mean diastolic BP \>/= 120mmHg
* Treated with other antihypertensive medication except diuretics or beta-blockers
* Type 1 diabetes mellitus
* Known cardiovascular disease including history of angina pectoris, heart failure, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and transient ischaemic attack) within the previous 12 months
* Renal insufficiency defined as a serum creatinine: \>/= 1.7 mg/dl
* Pregnancy or not using contraceptive in childbearing aged women
* Breast feeding women
* Any disease or condition that in the opinion of the investigator may interfere with completion of the study
20 Years
70 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Goyang, Gyeonggido, South Korea
Goyang-si, Gyeonggido, South Korea
Chungchungbuk-do, Korea, South Korea
Seoul, Korea, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Busan, , South Korea
Gwangju, , South Korea
Joong-gu, , South Korea
Kungki-do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Suwan, , South Korea
Countries
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References
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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.
Other Identifiers
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14696
Identifier Type: -
Identifier Source: org_study_id
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