Official Title: “A Double Blind, Randomised, 3-Arm Parallel Group, Multicentre, 8-Week, Phase III Study to Assess Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) /HCT 32/12.5mg and 32/25mg vs. CC 32mg Alone in Patients With Inadequate BP Control on Monotherapy With CC 32mg”

In this study it is intended to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg and the combination of candesartan 32 mg and HCT 12.5 mg to that of candesartan 32 mg alone in patients whose blood pressure is not well controlled on candesartan 32 mg monotherapy. The Primary Objectives are to compare sitting BP lowering effect of candesartan/HCT 32/25 mg and candesartan/HCT 32/12.5 mg with that of candesartan 32 mg, respectively.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2007

Intervention(s) in this Clinical Trial

• Drug: Candesartan cilexetil
  • 32mg oral
• Drug: Hydrochlorothiazide
  • 12.5 mg oral
• Drug: Hydrochlorothiazide
  • 25 mg oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Candesartan Cilexetil (CC) /HCT 32/12.5mg
• Experimental: 2
  • Candesartan Cilexetil (CC) /HCT 32/25mg
• Experimental: 3
  • Candesartan Cilexetil monotherapy

Primary Measures

• Change (reduction) in sitting BP (24 hours after dose)
  • Time Frame: Assessed from baseline (randomisation) to the end of the study.
    Safety Issue?: No

Secondary Measures

• Proportion of patients with controlled sitting BP in each treatment group
  • Time Frame: Assessed at the end of the study
    Safety Issue?: No
• Occurrence of Adverse Events and discontinuation of study medication due to AEs from baseline (randomisation) to the end of the study
  • Time Frame: Assessed from baseline (randomisation) to the end of the study.
    Safety Issue?: No

Inclusion Criteria:

• Patients will be eligible for enrolment into the study (Visit 1) if they fulfil all of the following criteria:
• Provision of signed Informed Consent
• Primary hypertension, untreated or treated with a maximum of 2 antihypertensive drugs, which the patient and the physician are willing to withdraw at enrolment and change to candesartan monotherapy
• Mean sitting DBP 90-114 mmHg
• Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
• Mean sitting DBP 90-114 mmHg on treatment with candesartan 32 mg monotherapy (after 2 weeks with candesartan 16 mg and 6 weeks with candesartan 32 mg monotherapy). The run-in period should not be shorter than 8 weeks.

Exclusion Criteria:

• Involvement in the planning and conduct of the study (applies to both AstraZeneca staff, CRO staff or staff at the investigational centre)
• Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant and verified by a negative pregnancy test at Visit 1
• Secondary or malignant hypertension
• Sitting SBP of 180 mmHg or more
• Patients who are treated with candesartan 16 mg in combination with a diuretic or with candesartan 32 mg with or without any additional antihypertensive treatment
• Myocardial infarction, stroke, coronary bypass surgery or transient ischaemic attack within 6 months before enrolment
• Angina pectoris requiring more treatment than short-acting nitrates
• Chronic use of NSAIDs
• Aortic or mitral valve stenosis
• Cardiac failure requiring treatment
• Cardiac arrhythmia requiring treatment
• Gout
• Renal artery stenosis or kidney transplantation
• Intravascular volume depletion
• Hypersensitivity to any component of the investigational products
• Concomitant disease which may interfere with the assessment of the patient
• Past or present alcohol or drug abuse, or any condition associated with poor compliance
• Chronic liver disease or known liver enzyme values above three times the upper limit of the reference range for S-ASAT or S-ALAT
• Concomitant or previous treatment with other investigational drugs within 20 days of enrolment
• Previous enrolment in the present study
• S-creatinine of 180 μmol/l or above for men and of 140 μmol/l or above for women
• S-sodium or S-potassium outside the reference range
• Less than 85% compliance with study medication during the run-in phase

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Established Brands HTN/CHF Medical Sience Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00383929

Study ID Number: D2456C00001

ClinicalTrials.gov Identifier: NCT00383929

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

AstraZeneca Information - Outside of the US