HypertensionPhase 4NCT01190007
Open Label Study To Evaluate The Long-Term Safety Profiles Of Caduet In Japanese Patients
A Phase 4 study testing Caduet in people with Hypertension and Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 20 sites in Japan.
Trial summary
The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension, Hypercholesterolemia, Angina Pectoris
- What is being tested?
- Caduet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 20 sitesJapan
- Study dates
- Aug 2010to Feb 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3):
- (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0)
- (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
- (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2
- Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3):
- (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and who meet the following criteria; Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0), and subjects with clinically stable of angina pectoris
- (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
- (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2
Who cannot join
- Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg.
- Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Masuda Clinic
Adachi-ku, Tokyo
Oofuji Clinic
Amagasaki, Hyōgo
Wakasugi Family Clinic
Arakawa-ku, Tokyo
Beppu Medical Clinic
Dazaifu, Fukuoka
Masunaga Clinic
Fujimi, Saitama
Yano Cardiovascular Clinic
Fukuoka
Sugiura Clinic
Kawaguchi, Saitama
Idaimae-naika Clinic
Kawasaki, Kanagawa
Morizono medical clinic
Kitakyushu, Fukuoka
Mizutani Clinic
Kobe, Hyōgo
Nada Clinic
Kobe, Hyōgo
Medical Care Law Person Corporation Kenseikai, Kobayashi Internal Medicine Clinic
Koto-ku, Tokyo
Healthcare Corporation MEDOC Medical Dock&Clinic
Nagoya, Aichi-ken
Gakkentoshi Clinic
Nishiku, Fukuoka
Banno Clinic
Ohta-ku, Tokyo
Nakaoka Clinic
Osaka
Department of internal gastro-intestinal medicine Ohshima clinic
Sapporo, Hokkaido
Hatano Medical Clinic
Setagaya-ku, Tokyo
Suzuki Circulatory Medical Clinic
Setagaya-ku, Tokyo
Sakakibara Clinic, Wakaumekai Medical Corporation
Yokohama, Kanagawa
About this study
Official title: A Multi-Center, Open Label Study To Evaluate Long Term Safety Of Caduet In Patient With Both Of Hypertension And Hypercholesterolemia, Or With Both Of Angina Pectoris And Hypercholesterolemia
The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.
- Conditions
- Hypertension, Hypercholesterolemia, Angina Pectoris
- Being tested
- Caduet
- Medical subject headings
- Hypertension, Hypercholesterolemia, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaduetDrug
One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Caduet | Experimental | Not described Receives: Drug: Caduet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: 52 weeks
Secondary outcomes (11)
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Value at each visits minus value at baseline
Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Value at each visits minus value at baseline
Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Value at each visits minus value at baseline
Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Value at each visits minus value at baseline
Measured: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Measured: Weeks 4, 12, 24, and 52
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Measured: Weeks 4, 12, 24, and 52
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Measured: Weeks 4, 12, 24, and 52
Percent Change From Baseline in Triglyceride (TG) at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Measured: Week 4, 12, 24, and 52
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline
Measured: Weeks 4, 12, 24, and 52
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Value at each visits minus value at baseline
Measured: Weeks 4, 12, 24, and 52
Percent Change From Baseline in Apolipoprotein B at Each Visit
"Value at each visits minus value at baseline" divided by value at baseline multiplied by 100
Measured: Week 4, 12, 24, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2012
- Study completionFeb 2012
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 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
- NCT01190007
- Sponsor's protocol ID
- A3841064
- Status last verified
- Jan 2021
- First submitted
- 5 Aug 2010
- Last updated
- 28 Jan 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open Label Study To Evaluate Long Term Safety Of Caduet In Patient With Both Of Hypertension And Hypercholesterolemia, Or With Both Of Angina Pectoris And Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01190007
- Acronym / sponsor ID
- A3841064
- Conditions
- Hypertension, Hypercholesterolemia, Angina Pectoris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Posted 3 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to investigate the safety of Caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of Amlodipine/Atorvastatin) during 52 weeks treatment period in Japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caduet | Experimental | Drug: Caduet |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3):
- (1) Subjects who take Amlodipine 2.5mg/day or 5mg/day at least 28 days before Week -2, and Subjects with well controlled BP value (BP value < 140/90mmHg at Week 0)
- (2) Subjects who take Atorvastatine 5mg/day or 10mg/day at least 28days before Week -2
- (3) Statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with LDL-C ≥ 160 mg/dL, LDL-C < 250 mg/dL, and TG < 400 mg/dL at Week -2
- Subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3):
Key exclusion criteria (2 listed)
- Subjects who need three or more multi-antihypertensive therapies to achieve the target BP level or uncontrolled status of hypertension at Week 0 (V1); the target BP level is defined as systolic blood pressure < 140mmHg and diastolic blood pressure < 90 mmHg.
- Uncontrolled or uncontrollable status of hypercholesterolemia at Week -2; A LDL-C ≥ 160 mg/dL even though Atorvastatine 10 mg has administrated
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 |
|---|---|---|
| CaduetOne Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks | Drug | Caduet |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 52 weeks
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
11 secondary outcomes
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Systolic Blood Pressure (SBP) at Each Visit in Population With Both Angina Pectoris and Hypercholesterolemia
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Both Hypertension and Hypercholesterolemia
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Trough Diastolic Blood Pressure (DBP) at Each Visit in Participant Population With Angina Pectoris and Hypercholesterolemia
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Each Visit
Time frame: Weeks 4, 12, 24, and 52
Percent Change From Baseline in Total Cholesterol (TC) at Each Visit
Time frame: Weeks 4, 12, 24, and 52
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Time frame: Weeks 4, 12, 24, and 52
Percent Change From Baseline in Triglyceride (TG) at Each Visit
Time frame: Week 4, 12, 24, and 52
Change From Baseline in Ratio of Low Density Lipoprotein Cholesterol (LDL-C) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Time frame: Weeks 4, 12, 24, and 52
Change From Baseline in Ratio of Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Each Visit
Time frame: Weeks 4, 12, 24, and 52
Percent Change From Baseline in Apolipoprotein B at Each Visit
Time frame: Week 4, 12, 24, and 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caduet in people with Hypertension and Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 20 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 8 inclusion and 2 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 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 3 Dec 2012). 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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 52 weeks). 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 28 Jan 2021.