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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT01071122

First received: February 18, 2010

Last updated: January 24, 2014

Last verified: January 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

February 18, 2010

Last Updated Date

January 24, 2014

Start Date ^ICMJE

January 2010

Primary Completion Date

February 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Central systolic blood pressure [ Time Frame: Week 8 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01071122 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in central diastolic blood pressure and pulse pressure [ Time Frame: Week 4,8 ]
Change in central systolic blood pressure [ Time Frame: Week 4 ]
Change in brachial systolic blood pressure and diastolic blood pressure [ Time Frame: Week 4,8 ]
Change in brachial pulse pressure [ Time Frame: Week4,8 ]
Change in augmentation index and augmentation pressure [ Time Frame: Week 4,8 ]
Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP) [ Time Frame: Week 4,8 ]
Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP [ Time Frame: Week 4,8 ]

Original Secondary Outcome Measures ^ICMJE

Central pulse pressure [ Time Frame: Week 8 ]
Augmentation index [ Time Frame: Week 8 ]
Augmentation pressure [ Time Frame: Week 8 ]
Brachial blood pressure [ Time Frame: Week 8 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Nifedipine (Adalat, BAYA1040) and Valsartan
Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
Drug: Nifedipine (Adalat, BAYA1040)
Nifedipine 60mg, Once daily
Drug: Valsartan
Valsartan 160mg, Once daily

Study Arms

Experimental: Arm 1
Intervention: Drug: Nifedipine (Adalat, BAYA1040) and Valsartan
Active Comparator: Arm 2
Intervention: Drug: Nifedipine (Adalat, BAYA1040)
Active Comparator: Arm 3
Intervention: Drug: Valsartan

Publications *

Park JB, Shin JH, Kim DS, Youn HJ, Park SW, Shim WJ, Park CG, Kim DW, Lee HY, Choi DJ, Rim SJ, Lee SY, Kim JH; FOCUS Investigators. Safety of the Up-titration of Nifedipine GITS and Valsartan or Low-dose Combination in Uncontrolled Hypertension: the FOCUS Study. Clin Ther. 2016 Apr;38(4):832-42. doi: 10.1016/j.clinthera.2016.02.025. Epub 2016 Mar 17.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

365

Completion Date

February 2012

Primary Completion Date

February 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

20 Years to 70 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01071122

Other Study ID Numbers ^ICMJE

14696

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Bayer

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

PRS Account

Bayer

Verification Date

January 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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