Back to resultsCandesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)
Primary Purpose
Hypertension, Left Ventricular Hypertrophy
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Candesartan
Candesartan
Felodipine
Felodipine
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring LVH
Eligibility Criteria
Inclusion Criteria: Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood pressure within 160-200 mm/Hg Patients diagnosed as left ventricular hypertrophy by electrocardiogram Exclusion Criteria: Secondary hypertension History of myocardial infarction Stroke within the previous 6 months
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Candesartan
Arm Description
Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Outcomes
Primary Outcome Measures
Percent Change of B Type Natriuretic Peptides (BNP) Level
Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.
Secondary Outcome Measures
LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index
Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area.
Change of Systolic Blood Pressure (SBP)
Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.
Change of Diastolic Blood Pressure (DBP)
Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.
Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only
Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine
Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00348686
Brief Title
Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)
Official Title
A Multicenter, Non-comparative, Phase IV Study to Evaluate the Effect of Candesartan Based Therapy in the Percent Change of proBNP Level After 24 Week Treatment in the Patients With Hypertension With Left Ventricular Hypertrophy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Left Ventricular Hypertrophy
Keywords
LVH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Candesartan
Arm Type
Experimental
Arm Description
Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
Intervention Type
Drug
Intervention Name(s)
Candesartan
Other Intervention Name(s)
Atacand
Intervention Description
16 mg once daily in oral tablet form
Intervention Type
Drug
Intervention Name(s)
Candesartan
Other Intervention Name(s)
Antacand
Intervention Description
32 mg once daily in oral tablet form
Intervention Type
Drug
Intervention Name(s)
Felodipine
Intervention Description
5 mg once daily in oral tablet form
Intervention Type
Drug
Intervention Name(s)
Felodipine
Intervention Description
10 mg once daily in oral tablet form
Primary Outcome Measure Information:
Title
Percent Change of B Type Natriuretic Peptides (BNP) Level
Description
Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.
Time Frame
At Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index
Description
Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area.
Time Frame
At Baseline and 24 weeks
Title
Change of Systolic Blood Pressure (SBP)
Description
Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.
Time Frame
At Baseline and 24 weeks
Title
Change of Diastolic Blood Pressure (DBP)
Description
Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.
Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.
Time Frame
At Baseline and 24 weeks
Title
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only
Description
Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
Time Frame
At Baseline and 24 weeks
Title
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine
Description
Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
Time Frame
At Baseline and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood pressure within 160-200 mm/Hg
Patients diagnosed as left ventricular hypertrophy by electrocardiogram
Exclusion Criteria:
Secondary hypertension
History of myocardial infarction
Stroke within the previous 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JeeWoong Son, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
BuSan
Country
Korea, Republic of
Facility Name
Research Site
City
CheonAn
Country
Korea, Republic of
Facility Name
Research Site
City
CheongJu
Country
Korea, Republic of
Facility Name
Research Site
City
Chunbuk
Country
Korea, Republic of
Facility Name
Research Site
City
DaeGu
Country
Korea, Republic of
Facility Name
Research Site
City
DaeJeon
Country
Korea, Republic of
Facility Name
Research Site
City
Gyungsangnamdo
Country
Korea, Republic of
Facility Name
Research Site
City
JeonJu
Country
Korea, Republic of
Facility Name
Research Site
City
KwangJu
Country
Korea, Republic of
Facility Name
Research Site
City
Pusan
Country
Korea, Republic of
Facility Name
Research Site
City
Ulsan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)
We'll reach out to this number within 24 hrs