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

Phase 4

Completed

• Conditions: Hypertension; Left Ventricular Hypertrophy
• Interventions: Drug: Candesartan; Drug: Felodipine

• Registration Number: NCT00348686
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-03
• Study First Submitted QC: 2006-07-03
• Study First Posted: 2006-07-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2009-06-08
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-05
• Last Update Submitted: 2012-03-05
• Results First Posted: 2012-04-02
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Candesartan	Felodipine	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.
Candesartan	Candesartan	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.

Primary Outcome Measures

Name	Time	Method
Percent Change of B Type Natriuretic Peptides (BNP) Level	At Baseline and 24 weeks	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

Name	Time	Method
Change of Diastolic Blood Pressure (DBP)	At Baseline and 24 weeks	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	At Baseline and 24 weeks	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	At Baseline and 24 weeks	Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index	At Baseline and 24 weeks	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)	At Baseline and 24 weeks	Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.

Trial Locations

Locations (1)

Research Site; 🇰🇷 Ulsan, Korea, Republic of