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

Phase 3

Completed

• Conditions: Hypertension; Hypercholesterolemia
• Interventions: Drug: Amlodipine 5mg/Atorvastatin 5mg; Drug: Amlodipine 2.5mg/Atorvastatin 5mg; Drug: Amlodipine 5mg/Atorvastatin 10mg; Drug: Amlodipine 2.5mg/Atorvastatin 10mg

• Registration Number: NCT00530946
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-14
• Study First Posted: 2007-09-18
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-03-10
• Results First Submitted QC: 2009-03-10
• Results First Posted: 2009-04-13
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CI-1038 5mg/5mg	Amlodipine 5mg/Atorvastatin 5mg	-
CI-1038 2.5mg/5mg	Amlodipine 2.5mg/Atorvastatin 5mg	-
CI-1038 5mg/10mg	Amlodipine 5mg/Atorvastatin 10mg	-
CI-1038 2.5mg/10mg	Amlodipine 2.5mg/Atorvastatin 10mg	-

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure	8 weeks	Value at Week 8 minus value at baseline
Percent Change in Low Density Lipoprotein-Cholesterol	8 weeks	Percent of "value at Week 8 minus value at baseline" over value at baseline

Secondary Outcome Measures

Name	Time	Method
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point	2 weeks, 4 weeks , and 8 weeks	Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Change in Diastolic Blood Pressure From Baseline to Each Observation Point	2 weeks, 4 weeks , and 8 weeks	Value at Week 2, Week 4, or Week 8 minus value at baseline
Change in Apolipoprotein B From Baseline to Each Observation Point	2 weeks, 4 weeks, and 8 weeks	Value at Week 2, Week 4, or Week 8 minus value at baseline
Percent Change in Total Cholesterol From Baseline to Each Observation Point	2 weeks, 4 weeks , and 8 weeks	Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Percent Change in Triglycerides From Baseline to Each Observation Point	2 weeks, 4 weeks , and 8 weeks	Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point	2 weeks, 4 weeks, and 8 weeks	Value at Week 2, Week 4, or Week 8 minus value at baseline
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point	2 weeks, 4 weeks , and 8 weeks	Value at Week 2, Week 4, or Week 8 minus value at baseline
Change in Systolic Blood Pressure From Baseline to Each Observation Point	2 weeks, 4 weeks, and 8 weeks	Value at Week 2, Week 4, or Week 8 minus value at baseline
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point	2 weeks, 4 weeks , and 8 weeks	Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Osaka, Japan