Clinical trial NCT01071122: FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Central blood pressure
Nifedipine
Valsartan
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 365
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Central systolic blood pressure
timeFrame: Week 8
Secondary outcomes:
measure: Change in central diastolic blood pressure and pulse pressure
timeFrame: Week 4,8
measure: Change in central systolic blood pressure
timeFrame: Week 4
measure: Change in brachial systolic blood pressure and diastolic blood pressure
timeFrame: Week 4,8
measure: Change in brachial pulse pressure
timeFrame: Week4,8
measure: Change in augmentation index and augmentation pressure
timeFrame: Week 4,8
measure: Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP)
timeFrame: Week 4,8
measure: Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP
timeFrame: Week 4,8
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
state: Gyeonggido
city: Goyang
country: Korea, Republic of
state: Gyeonggido
city: Chungchungbuk-do
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Joong-gu
country: Korea, Republic of
city: Kungki-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwan
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.