FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)

Tracking Information
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; (submitted: February 18, 2010)	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; (submitted: January 31, 2013)	Change in central diastolic blood pressure and pulse pressure [ Time Frame: Week 4,8 ]; Change in central systolic blood pressure [ Time Frame: Week 4 ]; Change in brachial systolic blood pressure and diastolic blood pressure [ Time Frame: Week 4,8 ]; Change in brachial pulse pressure [ Time Frame: Week4,8 ]; Change in augmentation index and augmentation pressure [ Time Frame: Week 4,8 ]; Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP) [ Time Frame: Week 4,8 ]; Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP [ Time Frame: Week 4,8 ]
Original Secondary Outcome Measures ICMJE; (submitted: February 18, 2010)	Central pulse pressure [ Time Frame: Week 8 ]; Augmentation index [ Time Frame: Week 8 ]; Augmentation pressure [ Time Frame: Week 8 ]; Brachial blood pressure [ Time Frame: Week 8 ]
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
Condition ICMJE	Hypertension
Intervention ICMJE	Drug: Nifedipine (Adalat, BAYA1040) and Valsartan Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily; Drug: Nifedipine (Adalat, BAYA1040) Nifedipine 60mg, Once daily; Drug: Valsartan Valsartan 160mg, Once daily
Study Arms	Experimental: Arm 1 Intervention: Drug: Nifedipine (Adalat, BAYA1040) and Valsartan; Active Comparator: Arm 2 Intervention: Drug: Nifedipine (Adalat, BAYA1040); Active Comparator: Arm 3 Intervention: Drug: Valsartan
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 30, 2012)	365
Original Estimated Enrollment ICMJE; (submitted: February 18, 2010)	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: Untreated grade 2 or grade 3 hypertension defined by mean diastolic blood pressure (BP) >/= 100 and/or mean systolic BP >/= 160mmHg without anti-hypertensive treatment or Treated grade 2 hypertension defined by mean diastolic BP >/= 100 and/or mean systolic BP >/=160mmHg with current diuretics and/or beta-blockers use for >/= 4 weeks Exclusion Criteria: Secondary form of hypertension; 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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years to 70 Years (Adult, Older Adult)
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	Study Director: Bayer Study Director Bayer
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