Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Hypertension
Intervention:	Drug: Amlodipine

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Among subjects who had completed the preceding study (A0531085, NCT00415623), where either Amlodipine 5 mg or 10 mg was administered for 8 weeks, those who were considered to be eligible for enrollment in this long-term study, based on safety and efficacy of the preceding study and who had a treatment compliance rate of at least 80% were enrolled.

	Description
Amlodipine	All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.

	Amlodipine
STARTED	134
COMPLETED	116
NOT COMPLETED	18
Adverse Event	16
Move	1
Withdrawal by Subject	1

	Description
Amlodipine	All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.

	Amlodipine
Number of Participants [units: participants]	134
Age, Customized [units: participants]
20 to 44 years	13
45 to 64 years	65
>=65 years	56
Gender [units: participants]
Female	61
Male	73

Outcome Measures

1. Primary:

Change in Systolic Blood Pressure From Baseline of the Preceding Study [ Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 1

2. Primary:

Change in Systolic Blood Pressure From Baseline of This Long-term Study [ Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 2

3. Primary:

Change in Diastolic Blood Pressure From Baseline of the Preceding Study [ Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 3

4. Primary:

Change in Diastolic Blood Pressure From Baseline of This Long-term Study [ Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 4

5. Primary:

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value [ 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 5

6. Primary:

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study [ 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 6

7. Other Pre-specified:

Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent [ Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Hide Outcome Measure 7

Measure Type	Other Pre-specified
Measure Title	Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent
Measure Description	Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Time Frame	Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 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 Case, n=number of subjects with evaluable data in group with concomitant treatment, without concomitant treatment, respectively.

Reporting Groups

	Description
Subjects With Concomitant Antihypertensive Agent	Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
Subjects Without Concomitant Antihypertensive Agent	Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).

Measured Values

	Subjects With Concomitant Antihypertensive Agent	Subjects Without Concomitant Antihypertensive Agent
Number of Participants Analyzed [units: participants]	13	121
Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent [units: mmHg] Mean ± Standard Deviation
Week 0: Baseline (Actual Value)	153.9 ± 10.8	148.3 ± 7.9
Week 8 (n=13, 121)	-4.8 ± 8.1	-9.1 ± 12.3
Week 10 (n=13, 118)	-13.8 ± 8.7	-14.8 ± 11.8
Week 12 (n=12, 119)	-13.5 ± 8.0	-15.8 ± 9.9
Week 16 (n=12, 117)	-17.2 ± 8.9	-16.4 ± 10.5
Week 20 (n=12, 116)	-10.8 ± 6.0	-16.1 ± 10.3
Week 24 (n=11, 113)	-13.8 ± 14.0	-14.8 ± 10.2
Week 28 (n=12, 111)	-15.1 ± 10.9	-13.6 ± 10.4
Week 32 (n=12, 111)	-4.8 ± 13.9	-14.0 ± 11.7
Week 36 (n=11, 108)	-4.8 ± 13.2	-13.1 ± 11.5
Week 40 (n=12, 108)	-9.6 ± 8.3	-13.6 ± 10.9
Week 44 (n=11, 108)	-13.7 ± 8.3	-15.4 ± 12.0
Week 48 (n=9, 107)	-11.1 ± 12.5	-15.3 ± 10.6
Week 52 (n=9, 106)	-10.8 ± 8.5	-15.9 ± 11.0

No statistical analysis provided for Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

8. Other Pre-specified:

Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent [ Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 8

9. Other Pre-specified:

Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent [ Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 9

10. Other Pre-specified:

Change in Diastolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent [ Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 10

11. Other Pre-specified:

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value in Treatment Groups With or Without Concomitant Antihypertensive Agent [ 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 11

12. Other Pre-specified:

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent [ 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]

Show Outcome Measure 12

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
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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 ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0531086
Study First Received:	March 2, 2007
Results First Received:	June 10, 2009
Last Updated:	October 19, 2009
ClinicalTrials.gov Identifier:	NCT00443456 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare