Candesartan Effect in Second Stage Arterial Hypertension

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

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 From Baseline After 4 Weeks of Therapy
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Changes in Mean Sitting SBP From Baseline After 4 Weeks of Therapy
  • Time Frame: 4 weeks
    Safety Issue?: No
• Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 4 Weeks of Therapy
  • Time Frame: 4 weeks
    Safety Issue?: No
• Proportion of Patients Achieving Goal of Mean Trough Sitting DBP (<90 mmHg, But <80 mmHg for DM & Chronic Kidney Disease) and SBP (<140 mmHg, But <130 mmHg for DM & Chronic Kidney Disease) After 8 Weeks of Therapy
  • Time Frame: 8 weeks
    Safety Issue?: No
• Changes in Mean Sitting SBP From Baseline After 8 Weeks of Therapy
  • Time Frame: 8 weeks
    Safety Issue?: No
• Changes in Hs-CRP Level From Baseline After 8 Weeks of Therapy
  • Time Frame: 8 weeks
    Safety Issue?: No
• Occurrence of Adverse Events (AE) and Discontinuation of Study Medication Due to AE's From Baseline (Randomisation) to the End of the Study (8 Weeks)
  • Time Frame: 8 weeks
    Safety Issue?: No
• Compliance Levels at 4 Weeks and 8 Weeks of Therapy
  • Time Frame: 8 weeks
    Safety Issue?: No

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

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 Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Dong Hoon Choi Principal Investigator Severance Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

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