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

Viatris

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hypercholesterolemia

Treatments: Drug: Amlodipine 2.5mg/Atorvastatin 10mg; Drug: Amlodipine 5mg/Atorvastatin 5mg; Drug: Amlodipine 5mg/Atorvastatin 10mg; Drug: Amlodipine 2.5mg/Atorvastatin 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530946

A3841058

Details and patient eligibility

About

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

Enrollment: 165 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 4 patient groups

CI-1038 2.5mg/5mg

Active Comparator group

Treatment:

Drug: Amlodipine 2.5mg/Atorvastatin 5mg

CI-1038 2.5mg/10mg

Active Comparator group

Treatment:

Drug: Amlodipine 2.5mg/Atorvastatin 10mg

CI-1038 5mg/5mg

Active Comparator group

Treatment:

Drug: Amlodipine 5mg/Atorvastatin 5mg

CI-1038 5mg/10mg

Active Comparator group

Treatment:

Drug: Amlodipine 5mg/Atorvastatin 10mg