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

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ClinicalTrials.gov Identifier: NCT00348686
Recruitment Status : Completed
First Posted : July 6, 2006
Results First Posted : April 2, 2012
Last Update Posted : April 2, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Left Ventricular Hypertrophy Drug: Candesartan Drug: Felodipine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Atacand

Drug: Candesartan
32 mg once daily in oral tablet form
Other Name: Antacand

Drug: Felodipine
5 mg once daily in oral tablet form

Drug: Felodipine
10 mg once daily in oral tablet form


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change of B Type Natriuretic Peptides (BNP) Level [ Time Frame: 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 :
  1. LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index [ Time Frame: 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.

  2. Change of Systolic Blood Pressure (SBP) [ Time Frame: At Baseline and 24 weeks ]
    Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.

  3. Change of Diastolic Blood Pressure (DBP) [ Time Frame: 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.


  4. Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only [ Time Frame: 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.

  5. Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348686


Locations
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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, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: JeeWoong Son, MD AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00348686    
Other Study ID Numbers: D2452L00012
CAP
First Posted: July 6, 2006    Key Record Dates
Results First Posted: April 2, 2012
Last Update Posted: April 2, 2012
Last Verified: March 2012
Keywords provided by AstraZeneca:
LVH
Additional relevant MeSH terms:
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Hypertension
Hypertrophy, Left Ventricular
Hypertrophy
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases
Felodipine
Candesartan
Candesartan cilexetil
 Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents