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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434967
• Other study ID #: D2456C00002
• Secondary ID: EudraCT No. 2006
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2007
• Last updated: November 30, 2010
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2207
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Candesartan cilexetil
32 mg oral tablet
• Hydrochlorothiazide
25 mg oral tablet
• Candesartan/HCT 32/25 mg

Locations

Country	Name	City	State
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
Latvia	Research Site	Daugavpils
Latvia	Research Site	Ogre
Latvia	Research Site	Riga
Malta	Research Site	Gozo
Malta	Research Site	Gwardiamangia
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
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Levice
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Presov
Slovakia	Research Site	Sahy

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Latvia,  Malta,  Romania,  Russian Federation,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sitting Diastolic Blood Pressure (DBP) From Baseline to the End of the Study (From Baseline to 8 Weeks).	Change (reduction) in sitting DBP at the end of the study, when compared to sitting DBP at baseline.	8 weeks	No
Primary	Change in Sitting Systolic Blood Pressure (SBP) From Baseline to the End of the Study (Baseline to 8 Weeks)	Change (reduction) in sitting SBP at the end of the study, when compared to sitting SBP at baseline.	8 weeks	No
Secondary	The Number of Patients With Controlled Sitting DBP and Sitting SBP in Each Treatment Group at the End of the Study	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	8 weeks	No
Secondary	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).		Baseline to 8 weeks	No
Secondary	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.		Baseline to 8 weeks	No
Secondary	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.		Baseline to 8 weeks	No
Secondary	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).		Baseline to 8 weeks	No
Secondary	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).		Baseline to 8 weeks	No

External Links

•   AstraZeneca Clinical Trial Information - Outside US