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

Bayer

Status and phase

Completed

Phase 4

Conditions

Hypertension

Treatments

Drug: Valsartan

Drug: Nifedipine (Adalat, BAYA1040) and Valsartan

Drug: Nifedipine (Adalat, BAYA1040)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01071122

14696

Details and patient eligibility

About

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

Enrollment

365 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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