check_circleStudy Completed

Hypertension

Bayer Identifier:

14696

ClinicalTrials.gov Identifier:

NCT01071122

EudraCT Number:

Not Available

EU CT Number:

Not Available
FOCUS (Nifedipine GITS's effect on Central pressure assessed by applanation tonometry)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

20 - 70 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
365
Trial Dates
January 2010 - February 2012
Phase
Phase 4
Could I Receive a placebo
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Ajou University HospitalSuwan, 443-721, Korea, Republic Of
Completed
St. Mary HospitalSeoul, 137-701, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Korea University Guro HospitalSeoul, 152-703, Korea, Republic Of
Completed
Chungbuk National University HospitalChungchungbuk-do, 361-711, Korea, Republic Of
Completed
Seoul National Univ. Bundang HospitalKungki-do, 463-707, Korea, Republic Of
Completed
Severance Hospital, Yonsei University College of MedicineSeoul, 120-752, Korea, Republic Of
Completed
Inje University Ilsan Paik HospitalGoyang-si, 411-706, Korea, Republic Of
Completed
Chonnam National University HospitalGwangju, 501-757, Korea, Republic Of
Completed
Cheil general HospitalJoong-gu, 100-380, Korea, Republic Of
Completed
Inje University Paik HospitalBusan, Korea, Republic Of
Completed
St. Mary HospitalSeoul, 137-701, Korea, Republic Of
Completed
Korea University Anam HospitalSeoul, 136-705, Korea, Republic Of
Completed
Dongguk University HospitalGoyang, 410-773, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Gangnam Service HospitalSeoul, 135-720, Korea, Republic Of

Primary Outcome

  • Central systolic blood pressure
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change in central diastolic blood pressure and pulse pressure
    date_rangeTime Frame:
    Week 4,8
    enhanced_encryption
    Safety Issue:
    No
  • Change in central systolic blood pressure
    date_rangeTime Frame:
    Week 4
    enhanced_encryption
    Safety Issue:
    No
  • Change in brachial systolic blood pressure and diastolic blood pressure
    date_rangeTime Frame:
    Week 4,8
    enhanced_encryption
    Safety Issue:
    No
  • Change in brachial pulse pressure
    date_rangeTime Frame:
    Week4,8
    enhanced_encryption
    Safety Issue:
    No
  • Change in augmentation index and augmentation pressure
    date_rangeTime Frame:
    Week 4,8
    enhanced_encryption
    Safety Issue:
    No
  • Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP)
    date_rangeTime Frame:
    Week 4,8
    enhanced_encryption
    Safety Issue:
    No
  • Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP
    date_rangeTime Frame:
    Week 4,8
    enhanced_encryption
    Safety Issue:
    No

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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