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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00348686
Collaborator
(none)
315
Enrollment
11
Locations
1
Arm
24
Duration (Months)
28.6
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 :
Jun 1, 2006
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site BuSan Korea, Republic of
    2 Research Site CheonAn Korea, Republic of
    3 Research Site CheongJu Korea, Republic of
    4 Research Site Chunbuk Korea, Republic of
    5 Research Site DaeGu Korea, Republic of
    6 Research Site DaeJeon Korea, Republic of
    7 Research Site Gyungsangnamdo Korea, Republic of
    8 Research Site JeonJu Korea, Republic of
    9 Research Site KwangJu Korea, Republic of
    10 Research Site Pusan Korea, Republic of
    11 Research Site Ulsan Korea, Republic of

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: JeeWoong Son, MD, AstraZeneca

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00348686
    Other Study ID Numbers:
    • D2452L00012
    • CAP
    First Posted:
    Jul 6, 2006
    Last Update Posted:
    Apr 2, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by AstraZeneca
    LVH
    Additional relevant MeSH terms:
    Hypertension
    Hypertrophy, Left Ventricular
    Hypertrophy
    Felodipine
    Candesartan
    Candesartan cilexetil

    Study Results

    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 Detail Screening period: Laboratory test (Creatinine, potassium, ALT, etc)
    Arm/Group Title Candesartan
    Arm/Group Description 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.
    Period Title: Overall Study
    STARTED 315
    COMPLETED 249
    NOT COMPLETED 66

    Baseline Characteristics

    Arm/Group Title Candesartan
    Arm/Group Description
    Overall Participants 315
    Age (years) [Mean (Standard Deviation) ]
    Average age of subjects who participated
    49.90
    (11.9)
    Sex: Female, Male (Count of Participants)
    Female
    81
    25.7%
    Male
    234
    74.3%

    Outcome Measures

    1. Primary Outcome
    Title Percent Change of B Type Natriuretic Peptides (BNP) Level
    Description 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.
    Time Frame At Baseline and 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Followed Intent-to-treat analysis
    Arm/Group Title Candesartan
    Arm/Group Description 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.
    Measure Participants 292
    Median (Full Range) [Percent Change]
    -29.2
    2. Secondary Outcome
    Title LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index
    Description 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.
    Time Frame At Baseline and 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Only 245 patients who have reliable Echocardiac data were analyzed.
    Arm/Group Title Candesartan
    Arm/Group Description 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.
    Measure Participants 245
    Median (Full Range) [g/m^2]
    -10.90
    3. Secondary Outcome
    Title Change of Systolic Blood Pressure (SBP)
    Description Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.
    Time Frame At Baseline and 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Only who has systolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.
    Arm/Group Title Candesartan
    Arm/Group Description 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.
    Measure Participants 302
    Median (Full Range) [mmHg]
    -32.0
    4. Secondary Outcome
    Title Change of Diastolic Blood Pressure (DBP)
    Description 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.
    Time Frame At Baseline and 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Last Observational carried forward
    Arm/Group Title Candesartan
    Arm/Group Description 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.
    Measure Participants 302
    Median (Full Range) [mmHg]
    -20.0
    5. Secondary Outcome
    Title Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only
    Description Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
    Time Frame At Baseline and 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Only 201 patients are available for analysis.
    Arm/Group Title Candesartan
    Arm/Group Description 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.
    Measure Participants 201
    Median (Full Range) [percent change]
    -18.9
    6. Secondary Outcome
    Title Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine
    Description Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
    Time Frame At Baseline and 24 weeks

    Outcome Measure Data

    Analysis Population Description
    Only 91 patients are available for analysis
    Arm/Group Title Candesartan
    Arm/Group Description 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.
    Measure Participants 91
    Median (Full Range) [percent change]
    -36.1

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Candesartan
    Arm/Group Description
    All Cause Mortality
    Candesartan
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Candesartan
    Affected / at Risk (%) # Events
    Total 8/ (NaN)
    Cardiac disorders
    Acute myocardial infarction 1/315 (0.3%)
    Gastrointestinal disorders
    Left paraduodenal hernia 1/315 (0.3%)
    Rectal prolapse aggravated 1/315 (0.3%)
    General disorders
    Cervical disc herniation aggravated 1/315 (0.3%)
    Renal and urinary disorders
    Uterine myoma aggravated 1/315 (0.3%)
    Respiratory, thoracic and mediastinal disorders
    Pneumonia with effusion in the right chest 1/315 (0.3%)
    Skin and subcutaneous tissue disorders
    Granuloma inguinale 1/315 (0.3%)
    Vascular disorders
    Cerebral infarction 1/315 (0.3%)
    Other (Not Including Serious) Adverse Events
    Candesartan
    Affected / at Risk (%) # Events
    Total 37/ (NaN)
    Nervous system disorders
    Headache 23/315 (7.3%)
    Dizziness 16/315 (5.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Gerard Lynch
    Organization AstraZeneca
    Phone
    Email aztrial_results_posting@astrazeneca.com
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00348686
    Other Study ID Numbers:
    • D2452L00012
    • CAP
    First Posted:
    Jul 6, 2006
    Last Update Posted:
    Apr 2, 2012
    Last Verified:
    Mar 1, 2012