Trial Condition(s):

Hypertension

FOCUS (Nifedipine GITS's effect on Central pressure assessed by applanation tonometry)

Bayer Identifier:

14696

ClinicalTrials.gov Identifier:

NCT01071122

EudraCT Number:

Not Available

Study Completed

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

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
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Phase
4
Could I receive a placebo?
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Ajou University Hospital

Suwan, South Korea, 443-721

Status
Completed
 
Locations

St. Mary Hospital

Seoul, South Korea, 137-701

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Korea University Guro Hospital

Seoul, South Korea, 152-703

Status
Completed
 
Locations

Chungbuk National University Hospital

Chungchungbuk-do, South Korea, 361-711

Status
Completed
 
Locations

Seoul National Univ. Bundang Hospital

Kungki-do, South Korea, 463-707

Status
Completed
 
Locations

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea, 120-752

Status
Completed
 
Locations

Inje University Ilsan Paik Hospital

Goyang-si, South Korea, 411-706

Status
Completed
 
Locations

Chonnam National University Hospital

Gwangju, South Korea, 501-757

Status
Completed
 
Locations

Cheil general Hospital

Joong-gu, South Korea, 100-380

Status
Completed
 
Locations

Inje University Paik Hospital

Busan, South Korea

Status
Completed
 
Locations

Korea University Anam Hospital

Seoul, South Korea, 136-705

Status
Completed
 
Locations

Dongguk University Hospital

Goyang, South Korea, 410-773

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Gangnam Service Hospital

Seoul, South Korea, 135-720

Status
Completed
 

Trial Design