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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.165 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

165

Conditions

Hypertension Hypercholesterolemia

Interventions

Amlodipine 2.5mg/Atorvastatin 5mgDRUG

Single pill combination, dosed once daily for 8 weeks

Amlodipine 2.5mg/Atorvastatin 10mgDRUG

Single pill combination, dosed once daily for 8 weeks

Amlodipine 5mg/Atorvastatin 5mgDRUG

Single pill combination, dosed once daily for 8 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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.

Locations (17)

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Pfizer Investigational Site

Kitakyushu-shi, Fukuoka, Japan

Pfizer Investigational Site

Outcomes

Primary Outcomes

Change in Systolic Blood Pressure

Value at Week 8 minus value at baseline

Time frame: 8 weeks

Percent Change in Low Density Lipoprotein-Cholesterol

Percent of "value at Week 8 minus value at baseline" over value at baseline

Time frame: 8 weeks

Secondary Outcomes

Change in Systolic Blood Pressure From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline

Time frame: 2 weeks, 4 weeks, and 8 weeks

Change in Diastolic Blood Pressure From Baseline to Each Observation Point

Value at Week 2, Week 4, or Week 8 minus value at baseline

Time frame: 2 weeks, 4 weeks , and 8 weeks

Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point

Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

Time frame: 2 weeks, 4 weeks , and 8 weeks

Percent Change in Total Cholesterol From Baseline to Each Observation Point

Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

Time frame: 2 weeks, 4 weeks , and 8 weeks

Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point

Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

Time frame: 2 weeks, 4 weeks , and 8 weeks

Data from ClinicalTrials.gov

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