Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348686
• Other study ID #: D2452L00012
• Secondary ID: CAP
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2006
• Last updated: March 5, 2012
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

Drug:
• Candesartan
16 mg once daily in oral tablet form
• Candesartan
32 mg once daily in oral tablet form
• Felodipine
5 mg once daily in oral tablet form
• Felodipine
10 mg once daily in oral tablet form

Locations

Country	Name	City	State
Korea, Republic of	Research Site	BuSan
Korea, Republic of	Research Site	CheonAn
Korea, Republic of	Research Site	CheongJu
Korea, Republic of	Research Site	Chunbuk
Korea, Republic of	Research Site	DaeGu
Korea, Republic of	Research Site	DaeJeon
Korea, Republic of	Research Site	Gyungsangnamdo
Korea, Republic of	Research Site	JeonJu
Korea, Republic of	Research Site	KwangJu
Korea, Republic of	Research Site	Pusan
Korea, Republic of	Research Site	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Baseline and 24 weeks	No
Secondary	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.	At Baseline and 24 weeks	No
Secondary	Change of Systolic Blood Pressure (SBP)	Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.	At Baseline and 24 weeks	No
Secondary	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.	At Baseline and 24 weeks	No
Secondary	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.	At Baseline and 24 weeks	No
Secondary	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.	At Baseline and 24 weeks	No