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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Left Ventricular Hypertrophy
• Intervention / Treatment: Drug: Candesartan; Drug: Candesartan; Drug: Felodipine; Drug: Felodipine

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • 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, Korea, Republic of
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Candesartan; 16 mg once daily in oral tablet form; Other Names: Atacand; Drug: Candesartan; 32 mg once daily in oral tablet form; Other Names: Antacand; Drug: Felodipine; 5 mg once daily in oral tablet form; Drug: Felodipine; 10 mg once daily in oral tablet form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: JeeWoong Son, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: July 3, 2006
• First Submitted That Met QC Criteria: July 3, 2006
• First Posted (ESTIMATE): July 6, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): April 2, 2012
• Last Update Submitted That Met QC Criteria: March 5, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: LVH
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Cardiomegaly; Hypertension; Hypertrophy; Hypertrophy, Left Ventricular; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Candesartan; Felodipine; Candesartan cilexetil
• Other Study ID Numbers: D2452L00012; CAP