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Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg

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ClinicalTrials.gov Identifier: NCT00383929
Recruitment Status : Completed
First Posted : October 4, 2006
Last Update Posted : March 20, 2008
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Candesartan cilexetil Drug: Hydrochlorothiazide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1979 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Candesartan Cilexetil (CC) /HCT 32/12.5mg
Drug: Candesartan cilexetil
32mg oral
Other Name: ATACAND

Drug: Hydrochlorothiazide
12.5 mg oral
Other Name: HCTZ

Experimental: 2
Candesartan Cilexetil (CC) /HCT 32/25mg
Drug: Candesartan cilexetil
32mg oral
Other Name: ATACAND

Drug: Hydrochlorothiazide
25 mg oral
Other Name: HCTZ

Experimental: 3
Candesartan Cilexetil monotherapy
Drug: Candesartan cilexetil
32mg oral
Other Name: ATACAND

Primary Outcome Measures :
  1. Change (reduction) in sitting BP (24 hours after dose) [ Time Frame: Assessed from baseline (randomisation) to the end of the study. ]

Secondary Outcome Measures :
  1. Proportion of patients with controlled sitting BP in each treatment group [ Time Frame: Assessed at the end of the study ]
  2. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383929

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Sponsors and Collaborators
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Study Director: Established Brands HTN/CHF Medical Sience Director, MD AstraZeneca
Principal Investigator: Gerd Bonner, MD MEDIAN Kliniken Bad Krozingen
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ClinicalTrials.gov Identifier: NCT00383929    
Other Study ID Numbers: D2456C00001
Eudract No. 2005-005718-19
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: March 20, 2008
Last Verified: March 2008
Keywords provided by AstraZeneca:
Blood pressure reduction
combination therapy
candesartan cilexetil
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Candesartan cilexetil
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists