Clinical trial NCT00434967: Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Blood pressure reduction
combination therapy
candesartan cilexetil
hydrochlorothiazide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-02-14
Enrollment: 2207
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).
timeFrame: 8 weeks
measure: Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)
timeFrame: 8 weeks
Secondary outcomes:
measure: The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study
timeFrame: 8 weeks
measure: 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).
timeFrame: Baseline to 8 weeks
measure: 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.
timeFrame: Baseline to 8 weeks
measure: 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.
timeFrame: Baseline to 8 weeks
measure: 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).
timeFrame: Baseline to 8 weeks
measure: 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).
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Dour
country: Belgium
facility: Research Site
city: Gozée
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Linkebeek
country: Belgium
facility: Research Site
city: Marchovelette
country: Belgium
facility: Research Site
city: Ronquières
country: Belgium
facility: Research Site
city: Saint-Médard
country: Belgium
facility: Research Site
city: Steenokkerzel
country: Belgium
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Ogre
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Gozo
country: Malta
facility: Research Site
city: Gwardiamangia
country: Malta
facility: Research Site
city: Arad
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Targoviste
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Sahy
country: Slovakia
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Michael Klibaner, MD
role: STUDY_DIRECTOR
affiliation: DEOEC Institute of Cardiology
name: Istvan Edes, MD
role: PRINCIPAL_INVESTIGATOR
References: