NCT00530946

A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

Conditions

• Hypertension
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Amlodipine 2.5mg/Atorvastatin 5mg	Single pill combination, dosed once daily for 8 weeks
DRUG	Amlodipine 2.5mg/Atorvastatin 10mg	Single pill combination, dosed once daily for 8 weeks
DRUG	Amlodipine 5mg/Atorvastatin 5mg	Single pill combination, dosed once daily for 8 weeks
DRUG	Amlodipine 5mg/Atorvastatin 10mg	Single pill combination, dosed once daily for 8 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-09-18
• Last updated: 2021-01-28
• Results posted: 2009-04-13

Locations

17 sites across 1 country: Japan