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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00530946

First received: September 13, 2007

Last updated: April 28, 2009

Last verified: March 2009

History of Changes

Results First Received: March 10, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
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

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty (20) centers in Japan

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 301 subjects entered the 6-week diet observation period and the end of diet observation period, 165 subjects who met all the inclusion criteria for the treatment period and had no conflict to exclusion criteria were randomized to 4 CI-1038 groups.

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)

Participant Flow: Overall Study

	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
STARTED	43	41	41	40
COMPLETED	41	39	40	38
NOT COMPLETED	2	2	1	2
Adverse Event	1	2	1	1
Protocol Violation	0	0	0	1
Noncompliance	1	0	0	0

Baseline Characteristics

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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)
Total	Total of all reporting groups

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

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1. Primary:

Change in Systolic Blood Pressure [ Time Frame: 8 weeks ]

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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Measure Type	Secondary
Measure Title	Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Measure Description	Value at Week 2, Week 4, or Week 8 minus value at baseline
Time Frame	2 weeks, 4 weeks, and 8 weeks
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set, Observed Cases

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)

Measured Values

	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
Number of Participants Analyzed [units: participants]	43	41	41	40
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point [units: Ratio] Mean ± Standard Deviation
Week 2	-1.2 ± 0.58	-1.4 ± 0.42	-1.1 ± 0.49	-1.3 ± 0.53
Week 4	-1.3 ± 0.41	-1.4 ± 0.42	-1.2 ± 0.56	-1.4 ± 0.49
Week 8	-1.2 ± 0.37	-1.4 ± 0.44	-1.2 ± 0.52	-1.4 ± 0.52

No statistical analysis provided for Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point

10. Secondary:

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 ]

Show Outcome Measure 10

11. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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

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