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

Tracking Information

First Received Date ^ICMJE

September 13, 2007

Last Updated Date

April 28, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Systolic Blood Pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Percent Change in Low Density Lipoprotein-Cholesterol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The change in SBP and the percent change in LDL-C from baseline at Week 8 in the treatment period

Change History

Complete list of historical versions of study NCT00530946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Systolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
Change in Diastolic Blood Pressure From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
Percent Change in Total Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
Percent Change in Triglycerides From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks , and 8 weeks ] [ Designated as safety issue: No ]
Change in Apolipoprotein B From Baseline to Each Observation Point [ Time Frame: 2 weeks, 4 weeks, and 8 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

1.The changes in the following efficacy endpoints from baseline to each visit: SBP (except that at Week 8), DBP, LDL-C (except that at Week 8), TC, HDL-C, TG, LDL-C/HDL-C ratio, TC/HDL-C ratio and ApolipoproteinB.
2. Safety endpoints (Adverse events, laboratory tests, 12-lead ECG, pulse rate)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hypertension
Hypercholesterolemia

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

165

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 79 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00530946

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A3841058

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP