CClinicalTrials.gg
Sign In
CompletedNCT01071122Updated Jan 27, 2014

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

A Phase 4 interventional study of Nifedipine (Adalat, BAYA1040) and Valsartan and Nifedipine (Adalat, BAYA1040) in Hypertension, sponsored by Bayer. Completed at 15 sites in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-01-27.

Sponsored by Bayer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
365
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • Central blood pressure
  • Nifedipine
  • Valsartan
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 365 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
365 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Nifedipine (Adalat, BAYA1040) and Valsartan

  • Active comparator
    Arm 2

    Drug: Nifedipine (Adalat, BAYA1040)

  • Active comparator
    Arm 3

    Drug: Valsartan

Interventions

  • DrugNifedipine (Adalat, BAYA1040) and Valsartan

    Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily

  • DrugNifedipine (Adalat, BAYA1040)

    Nifedipine 60mg, Once daily

  • DrugValsartan

    Valsartan 160mg, Once daily

06

What researchers measure

Primary outcomes

  1. Central systolic blood pressure

    Time frame: Week 8

Secondary outcomes

  1. Change in central diastolic blood pressure and pulse pressure

    Time frame: Week 4,8

  2. Change in central systolic blood pressure

    Time frame: Week 4

  3. Change in brachial systolic blood pressure and diastolic blood pressure

    Time frame: Week 4,8

  4. Change in brachial pulse pressure

    Time frame: Week4,8

  5. Change in augmentation index and augmentation pressure

    Time frame: Week 4,8

  6. Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP)

    Time frame: Week 4,8

  7. Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP

    Time frame: Week 4,8

07

Study locations

15 sites
  • Goyang-si, Gyeonggido 411-706, Korea, Republic of
  • Goyang, Gyeonggido 410-773, Korea, Republic of
  • Chungchungbuk-do, Korea 361-711, Korea, Republic of
  • Seoul, Korea 135-720, Korea, Republic of
  • Seoul, Seoul Teugbyeolsi 152-703, Korea, Republic of
  • Busan, Korea, Republic of
  • Gwangju, 501-757, Korea, Republic of
  • Joong-gu, 100-380, Korea, Republic of
  • Kungki-do, 463-707, Korea, Republic of
  • Seoul, 110-744, Korea, Republic of
  • Seoul, 120-752, Korea, Republic of
  • Seoul, 135-710, Korea, Republic of
  • Seoul, 136-705, Korea, Republic of
  • Seoul, 137-701, Korea, Republic of
  • Suwan, 443-721, Korea, Republic of
08

References and documents

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. PubMed 26996246 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01071122
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Feb 19, 2010
Start date
Jan 2010
Primary completion
Feb 2012
Completion
Feb 2012
Last update
Jan 27, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypertension→

Other studies from this sponsor

Bayer

Start the discussion