FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)
Phase 4
Completed
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT01071122
- Lead Sponsor
- Bayer
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 365
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 Valsartan - Arm 1 Nifedipine (Adalat, BAYA1040) and Valsartan - Arm 2 Nifedipine (Adalat, BAYA1040) -
- Primary Outcome Measures
Name Time Method Central systolic blood pressure Week 8
- Secondary Outcome Measures
Name Time Method Change in central systolic blood pressure Week 4 Change in augmentation index and augmentation pressure Week 4,8 Change in brachial systolic blood pressure and diastolic blood pressure Week 4,8 Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP) Week 4,8 Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP Week 4,8 Change in central diastolic blood pressure and pulse pressure Week 4,8 Change in brachial pulse pressure Week4,8