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
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Nifedipine (Adalat, BAYA1040) and Valsartan
Drug: Nifedipine (Adalat, BAYA1040)
Drug: Valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Central systolic blood pressure [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 365
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nifedipine (Adalat, BAYA1040) and Valsartan
Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
Active Comparator: Arm 2 Drug: Nifedipine (Adalat, BAYA1040)
Nifedipine 60mg, Once daily
Active Comparator: Arm 3 Drug: Valsartan
Valsartan 160mg, Once daily

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071122

Locations
Korea, Republic of
Goyang, Gyeonggido, Korea, Republic of, 410-773
Goyang-si, Gyeonggido, Korea, Republic of, 411-706
Chungchungbuk-do, Korea, Korea, Republic of, 361-711
Seoul, Korea, Korea, Republic of, 135-720
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 152-703
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, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 137-701
Suwan, Korea, Republic of, 443-721
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01071122     History of Changes
Other Study ID Numbers: 14696
Study First Received: February 18, 2010
Last Updated: January 24, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Bayer:
Central blood pressure
Nifedipine
Valsartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nifedipine
Valsartan
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 20, 2014