Trial Condition(s):
Hypertension
FOCUS (Nifedipine GITS's effect on Central pressure assessed by applanation tonometry)
Bayer Identifier:
14696
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Ajou University Hospital Suwan, South Korea, 443-721 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Mary Hospital Seoul, South Korea, 137-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Korea University Guro Hospital Seoul, South Korea, 152-703 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chungbuk National University Hospital Chungchungbuk-do, South Korea, 361-711 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National Univ. Bundang Hospital Kungki-do, South Korea, 463-707 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Severance Hospital, Yonsei University College of Medicine Seoul, South Korea, 120-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inje University Ilsan Paik Hospital Goyang-si, South Korea, 411-706 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chonnam National University Hospital Gwangju, South Korea, 501-757 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cheil general Hospital Joong-gu, South Korea, 100-380 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Inje University Paik Hospital Busan, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Korea University Anam Hospital Seoul, South Korea, 136-705 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dongguk University Hospital Goyang, South Korea, 410-773 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gangnam Service Hospital Seoul, South Korea, 135-720 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Central systolic blood pressureTimeframe: Week 8
Secondary Outcome
- Change in central diastolic blood pressure and pulse pressureTimeframe: Week 4,8
- Change in central systolic blood pressureTimeframe: Week 4
- Change in brachial systolic blood pressure and diastolic blood pressureTimeframe: Week 4,8
- Change in brachial pulse pressureTimeframe: Week4,8
- Change in augmentation index and augmentation pressureTimeframe: Week 4,8
- Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP)Timeframe: Week 4,8
- Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BPTimeframe: Week 4,8
Additional Information
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