Study 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

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

Trial summary

Enrollment Goal

365

Trial Dates

January 2010 - February 2012

Phase

Phase 4

Could I Receive a placebo

Products

Adalat GITS (Nifedipine, BAYA1040)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Ajou University Hospital	Suwan, 443-721, Korea, Republic Of
Completed	St. Mary Hospital	Seoul, 137-701, Korea, Republic Of
Completed	Samsung Medical Center	Seoul, 135-710, Korea, Republic Of
Completed	Samsung Medical Center	Seoul, 135-710, Korea, Republic Of
Completed	Korea University Guro Hospital	Seoul, 152-703, Korea, Republic Of
Completed	Chungbuk National University Hospital	Chungchungbuk-do, 361-711, Korea, Republic Of
Completed	Seoul National Univ. Bundang Hospital	Kungki-do, 463-707, Korea, Republic Of
Completed	Severance Hospital, Yonsei University College of Medicine	Seoul, 120-752, Korea, Republic Of
Completed	Inje University Ilsan Paik Hospital	Goyang-si, 411-706, Korea, Republic Of
Completed	Chonnam National University Hospital	Gwangju, 501-757, Korea, Republic Of
Completed	Cheil general Hospital	Joong-gu, 100-380, Korea, Republic Of
Completed	Inje University Paik Hospital	Busan, Korea, Republic Of
Completed	St. Mary Hospital	Seoul, 137-701, Korea, Republic Of
Completed	Korea University Anam Hospital	Seoul, 136-705, Korea, Republic Of
Completed	Dongguk University Hospital	Goyang, 410-773, Korea, Republic Of
Completed	Seoul National University Hospital	Seoul, 110-744, Korea, Republic Of
Completed	Gangnam Service Hospital	Seoul, 135-720, Korea, Republic Of

Primary Outcome

Central systolic blood pressure
Time Frame:
Week 8
Safety Issue:
no

Secondary Outcome

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

Additional Information

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