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

February 18, 2010
January 24, 2014
January 2010
February 2012   (final data collection date for primary outcome measure)
Central systolic blood pressure [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01071122 on ClinicalTrials.gov Archive Site
  • Change in central diastolic blood pressure and pulse pressure [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
  • Change in central systolic blood pressure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Change in brachial systolic blood pressure and diastolic blood pressure [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
  • Change in brachial pulse pressure [ Time Frame: Week4,8 ] [ Designated as safety issue: No ]
  • Change in augmentation index and augmentation pressure [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
  • Response rate(≥10 mmHg decrease of brachial SBP and ≥5mmHg decrease of brachial DBP) [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
  • Control rate (≤140/90 mmHg, 130/80 mmHg for diabetes, of brachial BP [ Time Frame: Week 4,8 ] [ Designated as safety issue: No ]
  • Central pulse pressure [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Augmentation index [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Augmentation pressure [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Brachial blood pressure [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
365
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01071122
14696
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

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