HypertensionPhase 3NCT00415623
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
A Phase 3 study testing Amlodipine in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 14 sites in Japan.
Trial summary
The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 14 sitesJapan
- Study dates
- Jan 2007to Oct 2007
- 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
- Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg.
- Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg.
- Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg
- Patients with a screening treatment compliance rate >= 80%
Who cannot join
- Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Pfizer Investigational Site
Adachi-ku, Tokyo
Pfizer Investigational Site
Chikushino-shi, Fukuoka
Pfizer Investigational Site
Edogawa-ku, Tokyo
Pfizer Investigational Site
Fukuoka
Pfizer Investigational Site
Iruma, Saitama
Pfizer Investigational Site
Kasuya-gun, Fujuoka
Pfizer Investigational Site
Kitakyushu, Fukuoka
Pfizer Investigational Site
Koga, Fukuoka
Pfizer Investigational Site
Koshigaya, Saitama
Pfizer Investigational Site
Meguro-ku, Tokyo
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Sumida City, Tokyo
Pfizer Investigational Site
Yokohama, Kanagawa
About this study
Official title: A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg
- 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
Amlodipine 5mg/ day
AmlodipineDrug
Amlodipine 10mg/ day
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine 5mg | Active comparator | Not described Receives: Drug: Amlodipine |
| Amlodipine 10mg | 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 (SBP) From Baseline to Week 8
Mean change in the trough SBP
Measured: Baseline to Week 8
Secondary outcomes (9)
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8
Mean change in the trough DBP
Measured: Baseline to Week 8
Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)
Arithmetic mean of Week 6 \& Week 8 by patient for "Change from baseline in SBP at Week 6" and "Change from baseline in SBP at Week 8"
Measured: Baseline to Week 6 and Week 8
Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)
Arithmetic mean of Week 6 \& Week 8 by patient for "Change from baseline in DBP at Week 6" and "Change from baseline in DBP at Week 8"
Measured: Baseline to Week 6 and Week 8
Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8
Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old
Measured: Week 8
Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8
Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old
Measured: Week 6 and Week 8
Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8
Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old
Measured: Week 8
Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8
Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old
Measured: Week 6 and Week 8
Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg
Measured: Baseline, Week 4 and Week 8
Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionOct 2007
- Study completionOct 2007
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415623
- Sponsor's protocol ID
- A0531085
- Status last verified
- Jan 2021
- First submitted
- 21 Dec 2006
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
- ClinicalTrials.gov ID
- NCT00415623
- Acronym / sponsor ID
- A0531085
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 25 Dec 2006 (estimated)
- Results
- Posted 9 Dec 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amlodipine 5mg | Active comparator | Drug: Amlodipine |
| Amlodipine 10mg | 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 (4 listed)
- Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg.
- Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg.
- Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg
- Patients with a screening treatment compliance rate >= 80%
Key exclusion criteria (1 listed)
- Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension
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 |
|---|---|---|
| AmlodipineAmlodipine 5mg/ day | Drug | Amlodipine 5mg |
| AmlodipineAmlodipine 10mg/ day | Drug | Amlodipine 10mg |
Primary outcome
Change in Systolic Blood Pressure (SBP) From Baseline to Week 8
Time frame: Baseline to Week 8
Mean change in the trough SBP
9 secondary outcomes
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8
Time frame: Baseline to Week 8
Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)
Time frame: Baseline to Week 6 and Week 8
Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)
Time frame: Baseline to Week 6 and Week 8
Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8
Time frame: Week 8
Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8
Time frame: Week 6 and Week 8
Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8
Time frame: Week 8
Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8
Time frame: Week 6 and Week 8
Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg
Time frame: Baseline, Week 4 and Week 8
Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg
Time frame: Baseline, Week 4, and Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- 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
14 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's Upjohn has merged with Mylan to form Viatris Inc. at 14 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 4 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 Dec 2008). 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 (SBP) From Baseline to Week 8 (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2021.