Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hyperlipidemia

Treatments: Drug: Irbesartan; Drug: Irbesartan/Atorvastatin A; Drug: Irbesartan/Atorvastatin B; Drug: Atorvastatin B; Drug: Atorvastatin A; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01442987

HM-IBAT-301

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of coadministered Irbesartan and Atorvastatin in patients with hypertension and hyperlipidemia.

Enrollment: 230 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 19 and 75 years
• Signed informed consent

Exclusion criteria

• At screening, SPB ≥ 180mmHg or DBP ≥ 110mmHg or LDL-C > 250mg/dL or TG ≥ 400mg/dL
• Has a history of hypersensitivity to Angiotensin Ⅱ receptor blocker or HMG-CoA reductase inhibitor or component of this drug
• Has a history of multi-drug allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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230 participants in 6 patient groups, including a placebo group

Irbesartan/Atorvastatin A

Experimental group

Treatment:

Drug: Irbesartan/Atorvastatin A

Irbesartan

Active Comparator group

Treatment:

Drug: Irbesartan

Atorvastatin A

Active Comparator group

Treatment:

Drug: Atorvastatin A

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Irbesartan/Atorvastatin B

Experimental group

Treatment:

Drug: Irbesartan/Atorvastatin B

Atorvastatin B

Active Comparator group

Treatment:

Drug: Atorvastatin B