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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.

• The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,

• LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

Exclusion Criteria:

• Subjects who had experienced the following coronary artery disease within the past 3 months.

• Myocardial infarction

• Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)

• Any clinically meaningful valvular disease

• Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.