Candesartan Effect in Second Stage Arterial Hypertension (CAESAR)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Stage II Hypertension

Treatments: Drug: Candesartan Cilexetil; Drug: Hydrochlorothiazide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00621153

D2452L00016

Details and patient eligibility

About

To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen

Enrollment: 214 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with a maximum of 2 class of antihypertensive drugs

Exclusion criteria

• Current serum-creatinine >3 mg/dL, Current serum-potassium >5.5 mmol/L, 16.
• Pregnant or lactating women or women of childbearing potential who were not protected from pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 4 patient groups

1

Active Comparator group

Description:

Candesartan cilexetil 16mg monotherapy

Treatment:

Drug: Candesartan Cilexetil

Drug: Candesartan Cilexetil

2

Experimental group

Description:

Candesartan cilexetil 16mg/HCT combination therapy

Treatment:

Drug: Hydrochlorothiazide

Drug: Candesartan Cilexetil

Drug: Candesartan Cilexetil

3

Active Comparator group

Description:

candesartan cilexetil 32mg monotherapy

Treatment:

Drug: Candesartan Cilexetil

Drug: Candesartan Cilexetil

4

Experimental group

Description:

Candesartan Cilexetil 32 mg/HCT combination therapy

Treatment:

Drug: Hydrochlorothiazide

Drug: Candesartan Cilexetil

Drug: Candesartan Cilexetil