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

This study has been completed.

Study NCT00530946 Information provided by Pfizer

First Received: September 13, 2007 Last Updated: April 28, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Conditions:	Hypertension Hypercholesterolemia
Interventions:	Drug: Amlodipine 2.5mg/Atorvastatin 5mg Drug: Amlodipine 2.5mg/Atorvastatin 10mg Drug: Amlodipine 5mg/Atorvastatin 5mg Drug: Amlodipine 5mg/Atorvastatin 10mg

Participant Flow

Show Participant Flow

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
CI-1038 2.5 mg/5 mg	Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
CI-1038 2.5 mg/10 mg	Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
CI-1038 5 mg/5 mg	Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
CI-1038 5 mg/10 mg	Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)

Baseline Measures

	CI-1038 2.5 mg/5 mg	CI-1038 2.5 mg/10 mg	CI-1038 5 mg/5 mg	CI-1038 5 mg/10 mg	Total
Number of Participants [units: participants]	43	41	41	40	165
Age, Customized [units: participants]
<20 years	0	0	0	0	0
20 to 44 years	8	3	4	5	20
45 to 64 years	20	21	23	23	87
>=65 years	15	17	14	12	58
Gender [units: participants]
Female	23	28	25	22	98
Male	20	13	16	18	67
Region of Enrollment [units: participants]
Japan	43	41	41	40	165

Outcome Measures

Show All Outcome Measures

1. Primary:

Change in Systolic Blood Pressure [ 8 weeks ]

Show Outcome Measure 1

2. Primary:

Percent Change in Low Density Lipoprotein-Cholesterol [ 8 weeks ]

Show Outcome Measure 2

3. Secondary:

Change in Systolic Blood Pressure From Baseline to Each Observation Point [ 2 weeks, 4 weeks, and 8 weeks ]

Show Outcome Measure 3

4. Secondary:

Change in Diastolic Blood Pressure From Baseline to Each Observation Point [ 2 weeks, 4 weeks , and 8 weeks ]

Show Outcome Measure 4

5. Secondary:

Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ 2 weeks, 4 weeks , and 8 weeks ]

Show Outcome Measure 5

6. Secondary:

Percent Change in Total Cholesterol From Baseline to Each Observation Point [ 2 weeks, 4 weeks , and 8 weeks ]

Show Outcome Measure 6

7. Secondary:

Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point [ 2 weeks, 4 weeks , and 8 weeks ]

Show Outcome Measure 7

8. Secondary:

Percent Change in Triglycerides From Baseline to Each Observation Point [ 2 weeks, 4 weeks , and 8 weeks ]

Show Outcome Measure 8

9. Secondary:

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 ]

Show Outcome Measure 9

10. Secondary:

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 ]

Show Outcome Measure 10

11. Secondary:

Change in Apolipoprotein B From Baseline to Each Observation Point [ 2 weeks, 4 weeks, and 8 weeks ]

Show Outcome Measure 11

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3841058
Study First Received:	September 13, 2007
Results First Received:	March 10, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00530946 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare