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

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

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.

Reporting Groups

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

Participant Flow: Overall Study

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

Baseline Characteristics

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Reporting Groups

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

Baseline Measures

	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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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

Serious Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

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

Serious Adverse Events

	Amlodipine
Total, serious adverse events
# participants affected / at risk	8/134 (5.97%)
Cardiac disorders
Angina unstable ^†^A # participants affected / at risk	1/134 (0.75%)
Atrioventricular block ^†^A # participants affected / at risk	1/134 (0.75%)
Sick sinus syndrome ^†^A # participants affected / at risk	1/134 (0.75%)
Injury, poisoning and procedural complications
Fall ^†^A # participants affected / at risk	2/134 (1.49%)
Subdural haematoma ^†^A # participants affected / at risk	1/134 (0.75%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer ^†^A # participants affected / at risk	1/134 (0.75%)
Gum neoplasm malignant stage unspecified ^†^A # participants affected / at risk	1/134 (0.75%)
Malignant ascites ^†^A # participants affected / at risk	1/134 (0.75%)
Nervous system disorders
Cerebral infarction ^†^A # participants affected / at risk	1/134 (0.75%)
Dizziness postural ^†^A # participants affected / at risk	1/134 (0.75%)
Loss of consciousness ^†^A # participants affected / at risk	2/134 (1.49%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA 10.1

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
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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