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Completed

NCT Number: NCT00348686

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

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.

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Key information

Conditions

Hypertension Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Hypertrophy, Left Ventricular Left Ventricular Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Candesartan

Drug

16 mg once daily in oral tablet form

Other names: Atacand

Felodipine

Drug

5 mg once daily in oral tablet form

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 6, 2006
Registry last updated
Apr 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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