Efficacy and Safety of Irbesartan and Atorvastatin in Hypertension and Hyperlipidemia

Phase 3

Completed

• Conditions: Hypertension; Hyperlipidemia
• Interventions: Drug: Irbesartan/Atorvastatin A; Drug: Atorvastatin A; Drug: Placebo; Drug: Irbesartan/Atorvastatin B; Drug: Atorvastatin B; Drug: Irbesartan

• Registration Number: NCT01442987
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-12
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Irbesartan/Atorvastatin A	Irbesartan/Atorvastatin A	-
Atorvastatin A	Atorvastatin A	-
Placebo	Placebo	-
Irbesartan/Atorvastatin B	Irbesartan/Atorvastatin B	-
Atorvastatin B	Atorvastatin B	-
Irbesartan	Irbesartan	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline to 8 week in LDL-Cholesterol	baseline and 8 week
Change from baseline to 8 week in Blood Pressure.	baseline and 8 week

Secondary Outcome Measures

Name	Time	Method
Percentage of patients reaching treatment goals according to NCEP ATP III Guideline and Blood pressure responder rate according to JNC VII Guideline.	week 8

Trial Locations

Locations (1)

16 institutions including Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of