NCT00348686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

April 2, 2012

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

July 3, 2006

Results QC Date

June 8, 2009

Last Update Submit

March 5, 2012

Conditions

HypertensionLeft Ventricular Hypertrophy

Keywords

LVH

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index

    At Baseline and 24 weeks

  • Change of Systolic Blood Pressure (SBP)

    At Baseline and 24 weeks

  • Change of Diastolic Blood Pressure (DBP)

    At Baseline and 24 weeks

  • 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) in Patients With Candesartan Plus Felodipine

    At Baseline and 24 weeks

Study Arms (1)

Candesartan

EXPERIMENTAL

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: CandesartanDrug: Felodipine

Interventions

CandesartanDRUG

16 mg once daily in oral tablet form

Also known as: Atacand
Candesartan
FelodipineDRUG

5 mg once daily in oral tablet form

Candesartan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Secondary hypertension
  • History of myocardial infarction
  • Stroke within the previous 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Busan, South Korea

Location

Research Site

Cheonan, South Korea

Location

Research Site

Cheongju-si, South Korea

Location

Research Site

Chunbuk, South Korea

Location

Research Site

Daegu, South Korea

Location

Research Site

Daejeon, South Korea

Location

Research Site

Gyungsangnamdo, South Korea

Location

Research Site

Jeonju, South Korea

Location

Research Site

Kwangju, South Korea

Location

Research Site

Pusan, South Korea

Location

Research Site

Ulsan, South Korea

Location

MeSH Terms

Conditions

HypertensionHypertrophy, Left Ventricular

Interventions

candesartancandesartan cilexetilFelodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCardiomegalyHeart DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • JeeWoong Son, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2006

First Posted

July 6, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 2, 2012

Results First Posted

April 2, 2012

Record last verified: 2012-03

Locations

KR(11)