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Candesartan Effect in Second Stage Arterial Hypertension

Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage II Hypertension

Intervention: Candesartan Cilexetil (Drug); Hydrochlorothiazide (Drug); Candesartan Cilexetil (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Dong Hoon Choi, Principal Investigator, Affiliation: Severance Hospital
Joonwoo Bahn, Study Director, Affiliation: AstraZeneca Korea

Overall contact:
AstraZeneca Korea Clinical, Study Information, Phone: 82 2 2188 0951, Email: minjee.nam@astrazeneca.com

Summary

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

Clinical Details

Official title: Open-Label, Randomised, 2-Arm Parallel Group, Multicentre, 8-Week, Phase IV Study to Assess the Antihypertensive Efficacy and Safety of the Candesartan Cilexetil 16 mg and Hydrochlorothiazide 12.5 mg Combination Therapy in Comparison With Candesartan 16 mg Monotherapy in Hypertensive Adults

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: changes in mean sitting DBP

Secondary outcome: mean sitting SBP from baseline

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

AstraZeneca Korea Clinical, Study Information, Phone: 82 2 2188 0951, Email: minjee.nam@astrazeneca.com

Research Site, Seoul, Korea, Republic of; Recruiting
Additional Information

Starting date: February 2008
Last updated: September 22, 2008

Page last updated: November 03, 2008

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