Antihypertensive efficacy and safety of Candesartan/HCT 32/12.5 and 32/25 mg in comparison with Candesartan 32 mg

Study identifier:D2456C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

hypertension

Phase

Phase 3

Healthy volunteers

Study drug

Candesartan cilexetil, Hydrochlorothiazide

Sex

All

Actual Enrollment

1979

Study type

Interventional

Age

20 Years - 80 Years

Date

Study Start Date: 01 Sept 2006

Primary Completion Date: 01 Aug 2007

Study Completion Date: 01 Oct 2007

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion 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

No locations available

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

Documents available

AstraZeneca Information - Outside of the US
Download
https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1270&filename=CSR-D2456C00001.pdf
Download
CSR-D2456C00001.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Investigators

Principal Investigator

Established Brands HTN/CHF Medical Sience Director

AstraZeneca