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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00348686

Enrollment

315

Registered

2006-07-06

Start date

2006-06-30

Completion date

2008-06-30

Last updated

2012-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Left Ventricular Hypertrophy

Keywords

LVH

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.

Interventions

DRUGCandesartan

16 mg once daily in oral tablet form

DRUGFelodipine

5 mg once daily in oral tablet form

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

South Korea

Participant flow

Recruitment details

Milestone date: 15 June 2006 (FSI) \ 05 June 2008 (LSLV) Type of location: General Hospital; 333 subjects enrolled, but 18 subjects failed to be randomized, 315 subjects were randomized to study.

Pre-assignment details

Screening period: Laboratory test (Creatinine, potassium, ALT, etc)

Participants by arm

Arm	Count
Candesartan	315
Total	315

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	5
Overall Study	Lost to Follow-up	2
Overall Study	Multiple Reasons	8
Overall Study	Protocol Violation	6
Overall Study	Withdrawal by Subject	45

Baseline characteristics

Characteristic	Candesartan
Age Continuous Average age of subjects who participated	49.90 years STANDARD_DEVIATION 11.9
Sex: Female, Male Female	81 Participants
Sex: Female, Male Male	234 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	37 / —
serious Total, serious adverse events	8 / —

Outcome results

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.