NCT01071122

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

2.1 years

First QC Date

February 18, 2010

Last Update Submit

January 24, 2014

Conditions

Hypertension

Keywords

Central blood pressureNifedipineValsartan

Outcome Measures

Primary Outcomes (1)

  • Central systolic blood pressure

    Week 8

Secondary Outcomes (7)

  • Change in central diastolic blood pressure and pulse pressure

    Week 4,8

  • Change in central systolic blood pressure

    Week 4

  • Change in brachial systolic blood pressure and diastolic blood pressure

    Week 4,8

  • Change in brachial pulse pressure

    Week4,8

  • Change in augmentation index and augmentation pressure

    Week 4,8

  • +2 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL
Drug: Nifedipine (Adalat, BAYA1040) and Valsartan

Arm 2

ACTIVE COMPARATOR
Drug: Nifedipine (Adalat, BAYA1040)

Arm 3

ACTIVE COMPARATOR
Drug: Valsartan

Interventions

Nifedipine (Adalat, BAYA1040) and ValsartanDRUG

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

Arm 1
Nifedipine (Adalat, BAYA1040)DRUG

Nifedipine 60mg, Once daily

Arm 2
ValsartanDRUG

Valsartan 160mg, Once daily

Arm 3

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Goyang, Gyeonggido, 410-773, South Korea

Location

Unknown Facility

Goyang-si, Gyeonggido, 411-706, South Korea

Location

Unknown Facility

Chungchungbuk-do, Korea, 361-711, South Korea

Location

Unknown Facility

Seoul, Korea, 135-720, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 152-703, South Korea

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Gwangju, 501-757, South Korea

Location

Unknown Facility

Joong-gu, 100-380, South Korea

Location

Unknown Facility

Kungki-do, 463-707, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Seoul, 135-710, South Korea

Location

Unknown Facility

Seoul, 136-705, South Korea

Location

Unknown Facility

Seoul, 137-701, South Korea

Location

Unknown Facility

Suwan, 443-721, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 26996246DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

NifedipineValsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesAzolesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 19, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 27, 2014

Record last verified: 2014-01

Locations

KR(15)