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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

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.

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

Research Site

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

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.

Age Continuous

GenderNIH

Percent Change of B Type Natriuretic Peptides (BNP) Level

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.

Only 245 patients who have reliable Echocardiac data were analyzed.

LVH(Left Ventricular Hypertrophy) regression by echocardiac parameter, left ventricular mass index

Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.

Only who has systolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.

Change of Systolic Blood Pressure (SBP)

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.

Change of Diastolic Blood Pressure (DBP)

Percent change of proBNP(B type Natriuretic Peptides)  was calculated and collected through the way of Last Observational carried forward.

Only 201 patients are available for analysis.

Percent Change of proBNP(B type Natriuretic Peptides) in Patients Treated With Candesartan Only

Only 91 patients are available for analysis

Percent Change of proBNP(B type natriuretic peptides) in Patients With Candesartan Plus Felodipine

Overall Study

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

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=305&filename=CSR-D2452L00012.pdf

CSR-D2452L00012.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator