HypertensionPhase 3NCT00443456

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

A Phase 3 study testing Amlodipine in people with Hypertension, run by Pfizer at 9 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is… Read more about this study

Who is it for?: Ages 20 to 79 years
Conditions the study is for: Hypertension
What is being tested?: Amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 9 sitesJapan
Study dates: May 2007to Jun 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
Patients who had a treatment compliance rate of at least 80%

Who cannot join

The patient who met the discontinuation criteria in the preceding study A0531085

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Japan9 sites

Pfizer Investigational Site
Chikushino-shi, Fukuoka
Pfizer Investigational Site
Edogawa-ku, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Iruma, Saitama
Pfizer Investigational Site
Kitakyushu, Fukuoka
Pfizer Investigational Site
Koshigaya, Saitama
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Sumida-ku, Tokyo
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective

Read the detailed description

NCT00415623 (protocol A0531085)

Conditions: Hypertension
Being tested: Amlodipine
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AmlodipineDrug
Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

Study groups in NCT00443456
Study group	Role	What they receive
Single	Experimental	Not described Receives: Drug: Amlodipine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Systolic Blood Pressure From Baseline of the Preceding Study
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Measured: 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
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Measured: 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
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Measured: 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
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Measured: 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
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg
Measured: 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
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
Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Jun 2008

First posted6 Mar 2007 (estimated)
Study startMay 2007
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00443456
Sponsor's protocol ID: A0531086
Status last verified: Oct 2009
First submitted: 2 Mar 2007
Last updated: 28 Oct 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
ClinicalTrials.gov ID: NCT00443456
Acronym / sponsor ID: A0531086
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 6 Mar 2007 (estimated)
Results: Posted 9 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

NCT00415623 (protocol A0531085)

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single	Experimental	Drug: Amlodipine

Who may qualify

Ages: 20 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
Patients who had a treatment compliance rate of at least 80%

Key exclusion criteria (1 listed)

The patient who met the discontinuation criteria in the preceding study A0531085

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AmlodipineTwo tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks	Drug	Single

Primary outcome

Change in Systolic Blood Pressure From Baseline of the Preceding Study
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
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Change in Systolic Blood Pressure From Baseline of This Long-term Study
Time frame: 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
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Change in Diastolic Blood Pressure From Baseline of the Preceding Study
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
Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)
Change in Diastolic Blood Pressure From Baseline of This Long-term Study
Time frame: 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
Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)
Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value
Time frame: 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
Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg
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
Time frame: 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
Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For <= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For >= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg

Results and safety

Results posted to the registry on 9 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine	134	116

Primary outcome: Change in Systolic Blood Pressure From Baseline of the Preceding Study

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. Mean (Standard Deviation). Unit: mmHg

Measure	Amlodipine n = 134	The Preceding Study 5 mg Sub-set of This Long-term Study n = 69	The Preceding Study 10 mg Sub-set of This Long-term Study n = 65
Week 0: Baseline (Actual Value)	148.8 (8.3)	148.8 (8.0)	148.8 (8.7)
Week 8	-8.7 (12.0)	-5.6 (12.9)	-12.0 (10.1)
Week 10	-14.8 (11.5)	-14.5 (11.3)	-15.0 (11.8)
Week 12	-15.6 (10.0)	-15.6 (9.7)	-15.7 (10.4)
Week 16	-16.7 (10.7)	-16.9 (10.5)	-16.4 (10.9)
Week 20	-15.8 (10.4)	-17.4 (11.1)	-14.1 (9.4)
Week 24	-15.4 (11.2)	-16.1 (10.5)	-14.6 (11.9)
Week 28	-14.7 (11.3)	-15.7 (11.7)	-13.6 (11.0)

Population analysed: Full Analysis Set, Last Observation Carried Forward

Primary outcome: Change in Systolic Blood Pressure From Baseline of This Long-term Study

Time frame: 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. Mean (Standard Deviation). Unit: mmHg

Measure	Amlodipine n = 134	The Preceding Study 5 mg Sub-set of This Long-term Study n = 69	The Preceding Study 10 mg Sub-set of This Long-term Study n = 65
Week 8: Baseline (Actual Value)	140.1 (14.2)	143.2 (15.7)	136.8 (11.6)
Week 10	-6.0 (10.9)	-8.9 (11.2)	-3.0 (9.8)
Week 12	-6.9 (11.9)	-10.0 (13.6)	-3.7 (8.8)
Week 16	-8.0 (12.0)	-11.3 (13.3)	-4.4 (9.4)
Week 20	-7.1 (12.0)	-11.8 (12.7)	-2.1 (9.0)
Week 24	-6.7 (12.4)	-10.5 (12.7)	-2.6 (10.8)
Week 28	-6.0 (13.0)	-10.1 (13.9)	-1.6 (10.3)
Week 32	-5.1 (12.2)	-8.8 (13.0)	-1.2 (9.9)

Population analysed: Full Analysis Set, Last Observation Carried Forward

Primary outcome: Change in Diastolic Blood Pressure From Baseline of the Preceding Study

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. Mean (Standard Deviation). Unit: mmHg

Measure	Amlodipine n = 134	The Preceding Study 5 mg Sub-set of This Long-term Study n = 69	The Preceding Study 10 mg Sub-set of This Long-term Study n = 65
Week 0: Baseline (Actual Value)	86.3 (10.2)	87.6 (10.0)	84.8 (10.2)
Week 8	-3.1 (8.8)	-1.8 (9.4)	-4.5 (7.9)
Week 10	-6.4 (7.9)	-6.6 (7.7)	-6.3 (8.1)
Week 12	-6.9 (7.6)	-7.7 (7.9)	-6.0 (7.2)
Week 16	-7.3 (8.0)	-8.4 (8.0)	-6.2 (7.9)
Week 20	-7.2 (8.0)	-7.9 (8.0)	-6.4 (7.9)
Week 24	-6.8 (8.1)	-7.1 (8.6)	-6.5 (7.6)
Week 28	-6.8 (8.3)	-7.8 (8.9)	-5.7 (7.5)

Population analysed: Full Analysis Set, Last Observation Carried Forward

Primary outcome: Change in Diastolic Blood Pressure From Baseline of This Long-term Study

Time frame: 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. Mean (Standard Deviation). Unit: mmHg

Measure	Amlodipine n = 134	The Preceding Study 5 mg Sub-set of This Long-term Study n = 69	The Preceding Study 10 mg Sub-set of This Long-term Study n = 65
Week 8: Baseline (Actual Value)	83.1 (11.5)	85.8 (11.8)	80.3 (10.5)
Week 10	-3.3 (7.2)	-4.8 (7.5)	-1.7 (6.6)
Week 12	-3.7 (7.3)	-5.8 (8.1)	-1.5 (5.6)
Week 16	-4.2 (7.9)	-6.5 (8.3)	-1.7 (6.6)
Week 20	-4.1 (7.5)	-6.1 (8.3)	-1.9 (5.8)
Week 24	-3.7 (8.4)	-5.3 (8.4)	-2.0 (8.2)
Week 28	-3.7 (8.3)	-6.0 (8.8)	-1.2 (6.9)
Week 32	-3.6 (8.4)	-5.2 (8.3)	-1.9 (8.3)

Population analysed: Full Analysis Set, Last Observation Carried Forward

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Amlodipine	8 of 134 (6%)	50 of 134 (37.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amlodipine in people with Hypertension, run by Pfizer at 9 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Systolic Blood Pressure From Baseline of the Preceding Study (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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00443456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2009.