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Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00434967
Recruitment Status : Completed
First Posted : February 14, 2007
Results First Posted : June 17, 2009
Last Update Posted : December 16, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The aim is to compare the blood pressure lowering effect of the combination of candesartan cilexetil (candesartan) 32 mg and hydrochlorothiazide (HCT) 25 mg to that of candesartan 32 mg alone, HCT 25 mg alone and placebo in hypertensive adults.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Candesartan cilexetil Drug: Hydrochlorothiazide Drug: Candesartan/HCT 32/25 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised, 4-arm Parallel Group, Multicentre, 8-week, Phase III Study to Assess the Antihypertensive Efficacy and Safety of the Combination of Candesartan Cilexetil (CC) 32 mg and Hydrochlorothiazide (HCT) 25 mg Compared With CC 32 mg, HCT 25 mg and Placebo in Hypertensive Adults
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 4
Placebo
Active Comparator: 2
Candesartan cilexetil
Drug: Candesartan cilexetil
32 mg oral tablet
Other Name: ATACAND

Active Comparator: 3
Hydrochlorothiazide (HCT)
Drug: Hydrochlorothiazide
25 mg oral tablet
Other Name: HCTZ

Experimental: 1
Candesartan cilexetil + Hydrochlorothiazide Combination
Drug: Candesartan cilexetil
32 mg oral tablet
Other Name: ATACAND

Drug: Hydrochlorothiazide
25 mg oral tablet
Other Name: HCTZ

Drug: Candesartan/HCT 32/25 mg



Primary Outcome Measures :
  1. Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). [ Time Frame: 8 weeks ]
    Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.

  2. Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) [ Time Frame: 8 weeks ]
    Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.


Secondary Outcome Measures :
  1. The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study [ Time Frame: 8 weeks ]
    Controlled sitting SBP and sitting DBP are defined as having sitting SBP < 140 mmHg and sitting DBP < 90 mmHg at the end of the study

  2. Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Hypertension Control Rate at the End of the Study (Patients With Controlled Sitting SBP and Sitting DBP). [ Time Frame: Baseline to 8 weeks ]
  3. To Describe Safety and Tolerability of the Study Treatments With Regard to Adverse Events Including Those That Lead to Treatment Discontinuation as Well as With Regard to Pulse Rate, Laboratory, Electrocardiographic and Physical Examination Findings. [ Time Frame: Baseline to 8 weeks ]
  4. To Compare Treatment With Candesartan/HCT 32/25 mg to Each of Its Components With Regard to Change From Baseline to Week 8 in Standing DBP and Standing SBP. [ Time Frame: Baseline to 8 weeks ]
  5. To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Control Rate at the End of the Study (Patients With Controlled Sitting DBP Are Defined as Having a Sitting DBP <90 mmHg at the End of the Study). [ Time Frame: Baseline to 8 weeks ]
  6. To Compare Candesartan/HCT 32/25 mg to Its Components and to Placebo With Regard to Sitting DBP Responder Rate (Decrease in Sitting DBP ≥10 mmHg From Baseline to the End of the Study or a Sitting DBP <90 mmHg at the End of the Study). [ Time Frame: Baseline to 8 weeks ]


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
Criteria

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 (substances), which the patient and the physician are willing to withdraw at enrolment and replace with placebo.
  • Mean sitting DBP 90-114 mmHg (value calculated in the eCRF) at Visits 1 and 2
  • Patients will be eligible for randomisation (Visit 4) if they fulfil the following criterion:
  • Mean sitting DBP of 90-114 mmHg (value calculated in the eCRF) at the end of the 4-week single-blind placebo run-in period. The run-in period should not be shorter than 4 weeks.

Exclusion Criteria:

  • Pregnant or lactating women, or women of childbearing potential not practising an adequate method of contraception eg, intrauterine device, oral contraception or progesterone implant. Pregnancy must be excluded by a negative pregnancy test at Visit 1.
  • Secondary or malignant hypertension
  • Sitting SBP of 180 mmHg or more
  • 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 or to any sulphonamide derived drugs
  • 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 that in the opinion of the investigator might affect the patient's participation in the study
  • Chronic liver disease
  • Concomitant or previous treatment with any other investigational drug within 20 days of enrolment
  • Previous enrolment in the present study

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): NCT00434967


Locations
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Belgium
Research Site
Dour, Belgium
Research Site
Gozée, Belgium
Research Site
Hasselt, Belgium
Research Site
Linkebeek, Belgium
Research Site
Marchovelette, Belgium
Research Site
Ronquières, Belgium
Research Site
Saint-Médard, Belgium
Research Site
Steenokkerzel, Belgium
Latvia
Research Site
Daugavpils, Latvia
Research Site
Ogre, Latvia
Research Site
Riga, Latvia
Malta
Research Site
Gozo, Malta
Research Site
Gwardiamangia, Malta
Romania
Research Site
Arad, Romania
Research Site
Bucuresti, Romania
Research Site
Iasi, Romania
Research Site
Pitesti, Romania
Research Site
Ploiesti, Romania
Research Site
Targoviste, Romania
Research Site
Timisoara, Romania
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
Slovakia
Research Site
Bratislava, Slovakia
Research Site
Levice, Slovakia
Research Site
Lucenec, Slovakia
Research Site
Presov, Slovakia
Research Site
Sahy, Slovakia
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Michael Klibaner, MD AstraZeneca
Principal Investigator: Istvan Edes, MD DEOEC Institute of Cardiology

Additional Information:
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ClinicalTrials.gov Identifier: NCT00434967    
Other Study ID Numbers: D2456C00002
EudraCT No. 2006-003963-30
First Posted: February 14, 2007    Key Record Dates
Results First Posted: June 17, 2009
Last Update Posted: December 16, 2010
Last Verified: November 2010
Keywords provided by AstraZeneca:
Blood pressure reduction
combination therapy
candesartan cilexetil
hydrochlorothiazide
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Diuretics
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