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

January 24, 2014 updated by: Bayer

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
      • Gwangju, Korea, Republic of, 501-757
      • Joong-gu, Korea, Republic of, 100-380
      • Kungki-do, Korea, Republic of, 463-707
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-710
      • Seoul, Korea, Republic of, 136-705
      • Suwan, Korea, Republic of, 443-721
    • Gyeonggido
      • Goyang, Gyeonggido, Korea, Republic of, 410-773
      • Goyang-si, Gyeonggido, Korea, Republic of, 411-706
    • Korea
      • Chungchungbuk-do, Korea, Korea, Republic of, 361-711
      • Seoul, Korea, Korea, Republic of, 135-720
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 152-703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Nifedipine (Adalat, BAYA1040)
Nifedipine 60mg, Once daily
Experimental: Arm 1
Drug: Nifedipine (Adalat, BAYA1040) and Valsartan
Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
Active Comparator: Arm 3
Drug: Valsartan
Valsartan 160mg, Once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Central systolic blood pressure
Time Frame: Week 8
Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 18, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14696

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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