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OpenTrials
Completed

NCT Number: NCT01071122

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

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

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Goyang, Gyeonggido, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nifedipine (Adalat, BAYA1040) and Valsartan

Drug

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

Nifedipine (Adalat, BAYA1040)

Drug

Nifedipine 60mg, Once daily

valsartan

Drug

Valsartan 160mg, Once daily

Primary outcomes

  1. Central systolic blood pressure

    Time frame: Week 8

Secondary outcomes

  1. Change in central diastolic blood pressure and pulse pressure

    Time frame: Week 4,8

  2. Change in central systolic blood pressure

    Time frame: Week 4

  3. Change in brachial systolic blood pressure and diastolic blood pressure

    Time frame: Week 4,8

  4. Change in brachial pulse pressure

    Time frame: Week4,8

  5. Change in augmentation index and augmentation pressure

    Time frame: Week 4,8

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

    Time frame: Week 4,8

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

    Time frame: Week 4,8

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 19, 2010
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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