Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00383929

Purpose

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	Intervention	Phase
Hypertension	Drug: Candesartan cilexetil Drug: Hydrochlorothiazide	Phase III

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

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 (reduction) in sitting BP (24 hours after dose) [ Time Frame: Assessed from baseline (randomisation) to the end of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with controlled sitting BP in each treatment group [ Time Frame: Assessed at the end of the study ] [ Designated as 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. ] [ Designated as safety issue: No ]

Enrollment:	1979
Study Start Date:	September 2006
Study Completion Date:	October 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Candesartan Cilexetil (CC) /HCT 32/12.5mg	Drug: Candesartan cilexetil 32mg oral Drug: Hydrochlorothiazide 12.5 mg oral
2: Experimental Candesartan Cilexetil (CC) /HCT 32/25mg	Drug: Candesartan cilexetil 32mg oral Drug: Hydrochlorothiazide 25 mg oral
3: Experimental Candesartan Cilexetil monotherapy	Drug: Candesartan cilexetil 32mg oral

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, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383929

Show 134 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Established Brands HTN/CHF Medical Sience Director, MD	AstraZeneca
Principal Investigator:	Gerd Bonner, MD	MEDIAN Kliniken Bad Krozingen

More Information

Additional Information:

AstraZeneca Information - Outside of the US This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D2456C00001, Eudract No. 2005-005718-19
Study First Received:	October 3, 2006
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00383929 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Blood pressure reduction
combination therapy
candesartan cilexetil
hydrochlorothiazide

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Sodium Chloride Symporter Inhibitors
Diuretics
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide
Pharmacologic Actions

Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Candesartan cilexetil
Natriuretic Agents
Therapeutic Uses
Candesartan
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010