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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00434967

Purpose

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	Intervention	Phase
Hypertension	Drug: Candesartan cilexetil Drug: Hydrochlorothiazide Drug: Candesartan/HCT 32/25 mg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Hydrochlorothiazide CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.
Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	2207
Study Start Date:	January 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434967

Locations

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

Study Director:	Michael Klibaner, MD	AstraZeneca
Principal Investigator:	Istvan Edes, MD	DEOEC Institute of Cardiology

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00434967 History of Changes
Other Study ID Numbers:	D2456C00002, EudraCT No. 2006-003963-30
Study First Received:	February 13, 2007
Results First Received:	January 9, 2009
Last Updated:	November 30, 2010
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by AstraZeneca:

Blood pressure reduction
combination therapy
candesartan cilexetil
hydrochlorothiazide

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan cilexetil
Candesartan
Antihypertensive Agents
Hydrochlorothiazide
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
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

ClinicalTrials.gov processed this record on February 09, 2012