Candesartan Effectiveness Study in Pro-BNP - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00348686

Purpose

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	Intervention	Phase
Hypertension Left Ventricular Hypertrophy	Drug: Candesartan Drug: Felodipine Procedure: Study manual adherence	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Candesartan cilexetil CV 11974 Proline Felodipine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To investigate the percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy treated with candesartan [ Time Frame: assessed after 24 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

LVH regression [ Time Frame: assessed after 24 weeks of therapy ] [ Designated as safety issue: No ]
Change of systolic and diastolic blood pressure [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]
Percent change of proBNP in patients treated with candesartan only vs candesartan+felodipine [ Time Frame: assessed after 24 weeks of therapy ] [ Designated as safety issue: No ]
Change of mean ambulatory blood pressure [ Time Frame: assessed after 24 weeks of therapy ] [ Designated as safety issue: No ]
Change of collagen markers [ Time Frame: assessed after 24 weeks of therapy ] [ Designated as safety issue: No ]

Enrollment:	315
Study Start Date:	June 2006
Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

once daily oral tablet

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hypertension with diastolic blood pressure within 95-115mmHg or/and systolic blood pressure within 160-200 mmHg
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348686

Locations

Korea, Republic of
Research Site
DaeGu, Korea, Republic of
Research Site
BuSan, Korea, Republic of
Research Site
KwangJu, Korea, Republic of
Research Site
JeonJu, Korea, Republic of
Research Site
DaeJeon, Korea, Republic of
Research Site
ULSAN, Korea, Republic of
Research Site
CheongJu, Korea, Republic of
Research Site
Chunbuk, Korea, Republic of
Research Site
GYUNGSANGNAMDO, Korea, Republic of
Research Site
PUSAN, Korea, Republic of
Research Site
CheonAn, Korea, Republic of

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

JeeWoong Son, MD

AstraZeneca

More Information

Study ID Numbers:	D2452L00012, CAP
Study First Received:	July 3, 2006
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00348686
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by AstraZeneca:

LVH

Study placed in the following topic categories:

Candesartan cilexetil
Pathological Conditions, Anatomical
Calcium, Dietary
Hypertrophy, Left Ventricular
Hypertrophy
Heart Diseases

Candesartan
Vascular Diseases
Angiotensin II
Cardiomegaly
Felodipine
Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009