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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nifedipine (Adalat, BAYA1040) and Valsartan (Drug); Nifedipine (Adalat, BAYA1040) (Drug); Valsartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer


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

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Central systolic blood pressure

Secondary outcome:

Change in central diastolic blood pressure and pulse pressure

Change in central systolic blood pressure

Change in brachial systolic blood pressure and diastolic blood pressure

Change in brachial pulse pressure

Change in augmentation index and augmentation pressure

Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP)

Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP


Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.


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

Locations and Contacts

Busan, Korea, Republic of

Gwangju 501-757, Korea, Republic of

Joong-gu 100-380, Korea, Republic of

Kungki-do 463-707, Korea, Republic of

Seoul 110-744, Korea, Republic of

Seoul 120-752, Korea, Republic of

Seoul 135-710, Korea, Republic of

Seoul 136-705, Korea, Republic of

Seoul 137-701, Korea, Republic of

Suwan 443-721, Korea, Republic of

Goyang-si, Gyeonggido 411-706, Korea, Republic of

Goyang, Gyeonggido 410-773, Korea, Republic of

Chungchungbuk-do, Korea 361-711, Korea, Republic of

Seoul, Korea 135-720, Korea, Republic of

Seoul, Seoul Teugbyeolsi 152-703, Korea, Republic of

Additional Information

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Starting date: January 2010
Last updated: January 24, 2014

Page last updated: August 23, 2015

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