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”

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

Study Type: Interventional

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

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: Candesartan Cilexetil
  • Candesartan Cilexetil 16 mg oral
• Drug: Hydrochlorothiazide
  • Hydrochlorothiazide 12.5 mg
• Drug: Candesartan Cilexetil
  • Candesartan Cilexetil 32 mg oral

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Candesartan cilexetil 16mg monotherapy
• Experimental: 2
  • Candesartan cilexetil 16mg/HCT combination therapy
• Active Comparator: 3
  • candesartan cilexetil 32mg monotherapy
• Experimental: 4
  • Candesartan Cilexetil 32 mg/HCT combination therapy

Primary Measures

• changes in mean sitting DBP
  • Time Frame: 4 weeks from therapy
    Safety Issue?: No

Secondary Measures

• mean sitting SBP from baseline
  • Time Frame: after 4 weeks
    Safety Issue?: No

Inclusion Criteria:

• Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 1 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Dong Hoon Choi Principal Investigator Severance Hospital  

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

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00621153

Study ID Number: D2452L00016

ClinicalTrials.gov Identifier: NCT00621153

Health Authority: Korea: Food and Drug Administration