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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530946
• Other study ID #: A3841058
• Status: Completed
• Phase: Phase 3
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertension

Intervention

Drug:
• Amlodipine 2.5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
• Amlodipine 2.5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
• Amlodipine 5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
• Amlodipine 5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Annaka	Gunma
Japan	Pfizer Investigational Site	Chofu	Tokyo
Japan	Pfizer Investigational Site	Fukuoka-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Kita-ku	Osaka-fu
Japan	Pfizer Investigational Site	Kitakyushu-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Kiyose	Tokyo
Japan	Pfizer Investigational Site	Koshigaya-shi	Saitama-ken
Japan	Pfizer Investigational Site	Kurume-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Maebaru-shi	Fukuoka-ken
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Sapporo-shi	Hokkaido
Japan	Pfizer Investigational Site	Setagaya-ku	Tokyo
Japan	Pfizer Investigational Site	Shinagawa	Tokyo
Japan	Pfizer Investigational Site	Shinagawa-Ku	Tokyo
Japan	Pfizer Investigational Site	Teine	Hokkaido
Japan	Pfizer Investigational Site	Yamashita-cho	Naka-ku, Kanagawa-ken
Japan	Pfizer Investigational Site	Yokohama-shi	Kanagawa-ken

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

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