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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Hypercholesterolemia

Intervention: Amlodipine 2.5mg/Atorvastatin 5mg (Drug); Amlodipine 2.5mg/Atorvastatin 10mg (Drug); Amlodipine 5mg/Atorvastatin 5mg (Drug); Amlodipine 5mg/Atorvastatin 10mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in Systolic Blood Pressure

Percent Change in Low Density Lipoprotein-Cholesterol

Secondary outcome:

Change in Systolic Blood Pressure From Baseline to Each Observation Point

Change in Diastolic Blood Pressure From Baseline to Each Observation Point

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

Percent Change in Total Cholesterol From Baseline to Each Observation Point

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

Percent Change in Triglycerides From Baseline to Each Observation Point

Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point

Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point

Change in Apolipoprotein B From Baseline to Each Observation Point

Eligibility

Minimum age: 20 Years. Maximum age: 79 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Osaka, Japan

Pfizer Investigational Site, Fukuoka-shi, Fukuoka-ken, Japan

Pfizer Investigational Site, Kitakyushu-shi, Fukuoka-ken, Japan

Pfizer Investigational Site, Kurume-shi, Fukuoka-ken, Japan

Pfizer Investigational Site, Maebaru-shi, Fukuoka-ken, Japan

Pfizer Investigational Site, Annaka, Gunma, Japan

Pfizer Investigational Site, Sapporo-shi, Hokkaido, Japan

Pfizer Investigational Site, Teine, Hokkaido, Japan

Pfizer Investigational Site, Yokohama-shi, Kanagawa-ken, Japan

Pfizer Investigational Site, Yamashita-cho, Naka-ku, Kanagawa-ken, Japan

Pfizer Investigational Site, Kita-ku, Osaka-fu, Japan

Pfizer Investigational Site, Koshigaya-shi, Saitama-ken, Japan

Pfizer Investigational Site, Chofu, Tokyo, Japan

Pfizer Investigational Site, Kiyose, Tokyo, Japan

Pfizer Investigational Site, Setagaya-ku, Tokyo, Japan

Pfizer Investigational Site, Shinagawa-Ku, Tokyo, Japan

Pfizer Investigational Site, Shinagawa, Tokyo, Japan

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2007
Last updated: April 28, 2009

Page last updated: August 20, 2015

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