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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071122
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : January 27, 2014
Information provided by (Responsible Party):

February 18, 2010
February 19, 2010
January 27, 2014
January 2010
February 2012   (Final data collection date for primary outcome measure)
Central systolic blood pressure [ Time Frame: Week 8 ]
Same as current
Complete list of historical versions of study NCT01071122 on Archive Site
  • 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 ]
  • 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 ]
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FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)
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.
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
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
  • 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
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 Identifier (NCT Number) in Medline.
February 2012
February 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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Study Director: Bayer Study Director Bayer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP