Candesartan Effect in Second Stage Arterial Hypertension

NCT ID: NCT00621153

Last Updated: 2010-03-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-03-31

Brief Summary

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To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen

Detailed Description

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Conditions

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Stage II Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Candesartan cilexetil 16mg monotherapy

Group Type ACTIVE_COMPARATOR

Candesartan Cilexetil

Intervention Type DRUG

Candesartan Cilexetil 16 mg oral

2

Candesartan cilexetil 16mg/HCT combination therapy

Group Type EXPERIMENTAL

Candesartan Cilexetil

Intervention Type DRUG

Candesartan Cilexetil 16 mg oral

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 12.5 mg

3

candesartan cilexetil 32mg monotherapy

Group Type ACTIVE_COMPARATOR

Candesartan Cilexetil

Intervention Type DRUG

Candesartan Cilexetil 32 mg oral

4

Candesartan Cilexetil 32 mg/HCT combination therapy

Group Type EXPERIMENTAL

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 12.5 mg

Candesartan Cilexetil

Intervention Type DRUG

Candesartan Cilexetil 32 mg oral

Interventions

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Candesartan Cilexetil

Candesartan Cilexetil 16 mg oral

Intervention Type DRUG

Hydrochlorothiazide

Hydrochlorothiazide 12.5 mg

Intervention Type DRUG

Candesartan Cilexetil

Candesartan Cilexetil 32 mg oral

Intervention Type DRUG

Other Intervention Names

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Atacand HCTZ Diazide Atacand

Eligibility Criteria

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Inclusion Criteria

* Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs

Exclusion Criteria

* Current serum-creatinine \>3 mg/dL, Current serum-potassium \>5.5 mmol/L, 16.
* Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Dong Hoon Choi

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Joonwoo Bahn

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

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Research Site

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee HY, Hong BK, Chung WJ, Lee BK, Lee SH, Jeon DW, Ahn YK, Kim D, Park CK, Kim SH, Jung HO, Kim BO, Choi D. Phase IV, 8-week, multicenter, randomized, active treatment-controlled, parallel group, efficacy, and tolerability study of high-dose candesartan cilexetil combined with hydrochlorothiazide in Korean adults with stage II hypertension. Clin Ther. 2011 Aug;33(8):1043-56. doi: 10.1016/j.clinthera.2011.07.002. Epub 2011 Aug 10.

Reference Type DERIVED
PMID: 21831438 (View on PubMed)

Other Identifiers

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D2452L00016

Identifier Type: -

Identifier Source: org_study_id

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