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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01071122

Enrollment

365

Registered

2010-02-19

Start date

2010-01-31

Completion date

2012-02-29

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Central blood pressure, Nifedipine, Valsartan

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

Interventions

DRUGNifedipine (Adalat, BAYA1040) and Valsartan

Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily

DRUGNifedipine (Adalat, BAYA1040)

Nifedipine 60mg, Once daily

DRUGValsartan

Valsartan 160mg, Once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Central systolic blood pressure	Week 8

Secondary

Measure	Time frame
Change in central systolic blood pressure	Week 4
Change in brachial systolic blood pressure and diastolic blood pressure	Week 4,8
Change in brachial pulse pressure	Week4,8
Change in central diastolic blood pressure and pulse 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 augmentation index and augmentation pressure	Week 4,8

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026