HypertensionPhase 3NCT00530946

A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin

A Phase 3 study testing Amlodipine 2.5mg/Atorvastatin 5mg, Amlodipine 2.5mg/Atorvastatin 10mg and Amlodipine 5mg/Atorvastatin 5mg in people with Hypertension and Hypercholesterolemia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 17 sites in Japan.

Completed

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

Official record

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Trial summary

To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period Read more about this study

Who is it for?: Ages 20 to 79 years
Conditions the study is for: Hypertension, Hypercholesterolemia
What is being tested?: Amlodipine 2.5mg/Atorvastatin 5mg, Amlodipine 2.5mg/Atorvastatin 10mg and Amlodipine 5mg/Atorvastatin 5mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: 17 sitesJapan
Study dates: Sep 2007to Apr 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

The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

Who cannot join

Subjects who had experienced the following coronary artery disease within the past 3 months.
Myocardial infarction
Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
Any clinically meaningful valvular disease
Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Japan17 sites

Pfizer Investigational Site
Annaka, Gunma
Pfizer Investigational Site
Chōfu, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Kita-ku, Osaka
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka
Pfizer Investigational Site
Kiyose, Tokyo
Pfizer Investigational Site
Koshigaya-shi, Saitama
Pfizer Investigational Site
Kurume-shi, Fukuoka
Pfizer Investigational Site
Maebaru-shi, Fukuoka
Pfizer Investigational Site
Osaka
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Setagaya-ku, Tokyo
Pfizer Investigational Site
Shinagawa, Tokyo
Pfizer Investigational Site
Shinagawa-Ku, Tokyo
Pfizer Investigational Site
Teine, Hokkaido
Pfizer Investigational Site
Yamashitachō, Naka-ku, Kanagawa-ken
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia

To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

Conditions: Hypertension, Hypercholesterolemia
Being tested: Amlodipine 2.5mg/Atorvastatin 5mg, Amlodipine 2.5mg/Atorvastatin 10mg, Amlodipine 5mg/Atorvastatin 5mg, Amlodipine 5mg/Atorvastatin 10mg
Medical subject headings: Hypertension, Hypercholesterolemia

What participants receive

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

Amlodipine 2.5mg/Atorvastatin 5mgDrug
Single pill combination, dosed once daily for 8 weeks
Amlodipine 2.5mg/Atorvastatin 10mgDrug
Single pill combination, dosed once daily for 8 weeks
Amlodipine 5mg/Atorvastatin 5mgDrug
Single pill combination, dosed once daily for 8 weeks
Amlodipine 5mg/Atorvastatin 10mgDrug
Single pill combination, dosed once daily for 8 weeks

Study groups in NCT00530946
Study group	Role	What they receive
CI-1038 2.5mg/5mg	Active comparator	Not described Receives: Drug: Amlodipine 2.5mg/Atorvastatin 5mg
CI-1038 2.5mg/10mg	Active comparator	Not described Receives: Drug: Amlodipine 2.5mg/Atorvastatin 10mg
CI-1038 5mg/5mg	Active comparator	Not described Receives: Drug: Amlodipine 5mg/Atorvastatin 5mg
CI-1038 5mg/10mg	Active comparator	Not described Receives: Drug: Amlodipine 5mg/Atorvastatin 10mg

What is being measured

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

Change in Systolic Blood Pressure
Value at Week 8 minus value at baseline
Measured: 8 weeks
Percent Change in Low Density Lipoprotein-Cholesterol
Percent of "value at Week 8 minus value at baseline" over value at baseline
Measured: 8 weeks

Secondary outcomes (9)

Change in Systolic Blood Pressure From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Measured: 2 weeks, 4 weeks, and 8 weeks
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Measured: 2 weeks, 4 weeks , and 8 weeks
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Measured: 2 weeks, 4 weeks , and 8 weeks
Percent Change in Total Cholesterol From Baseline to Each Observation Point
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Measured: 2 weeks, 4 weeks , and 8 weeks
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Measured: 2 weeks, 4 weeks , and 8 weeks
Percent Change in Triglycerides From Baseline to Each Observation Point
Percent of "value at Week 2, Week 4, or Week 8 minus value at baseline" over value at baseline
Measured: 2 weeks, 4 weeks , and 8 weeks
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Measured: 2 weeks, 4 weeks, and 8 weeks
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Measured: 2 weeks, 4 weeks , and 8 weeks
Change in Apolipoprotein B From Baseline to Each Observation Point
Value at Week 2, Week 4, or Week 8 minus value at baseline
Measured: 2 weeks, 4 weeks, and 8 weeks

Timeline

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

Sep 2007Apr 2008

First posted18 Sep 2007 (estimated)
Study startSep 2007
Primary completionApr 2008
Study completionApr 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.
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: None (open label)
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00530946
Sponsor's protocol ID: A3841058
Status last verified: Jan 2021
First submitted: 13 Sep 2007
Last updated: 28 Jan 2021
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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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, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia
ClinicalTrials.gov ID: NCT00530946
Acronym / sponsor ID: A3841058
Conditions: Hypertension, Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 18 Sep 2007 (estimated)
Results: Posted 13 Apr 2009

Clinical summary

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

To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
CI-1038 2.5mg/5mg	Active comparator	Drug: Amlodipine 2.5mg/Atorvastatin 5mg
CI-1038 2.5mg/10mg	Active comparator	Drug: Amlodipine 2.5mg/Atorvastatin 10mg
CI-1038 5mg/5mg	Active comparator	Drug: Amlodipine 5mg/Atorvastatin 5mg
CI-1038 5mg/10mg	Active comparator	Drug: Amlodipine 5mg/Atorvastatin 10mg

Who may qualify

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

Key inclusion criteria (3 listed)

The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit 1.
The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

Key exclusion criteria (5 listed)

Subjects who had experienced the following coronary artery disease within the past 3 months.
Myocardial infarction
Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
Any clinically meaningful valvular disease
Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.

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
Amlodipine 2.5mg/Atorvastatin 5mgSingle pill combination, dosed once daily for 8 weeks	Drug	CI-1038 2.5mg/5mg
Amlodipine 2.5mg/Atorvastatin 10mgSingle pill combination, dosed once daily for 8 weeks	Drug	CI-1038 2.5mg/10mg
Amlodipine 5mg/Atorvastatin 5mgSingle pill combination, dosed once daily for 8 weeks	Drug	CI-1038 5mg/5mg
Amlodipine 5mg/Atorvastatin 10mgSingle pill combination, dosed once daily for 8 weeks	Drug	CI-1038 5mg/10mg

Primary outcome

Change in Systolic Blood Pressure
Time frame: 8 weeks
Value at Week 8 minus value at baseline
Percent Change in Low Density Lipoprotein-Cholesterol
Time frame: 8 weeks
Percent of "value at Week 8 minus value at baseline" over value at baseline

9 secondary outcomes

Change in Systolic Blood Pressure From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks, and 8 weeks
Change in Diastolic Blood Pressure From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks , and 8 weeks
Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks , and 8 weeks
Percent Change in Total Cholesterol From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks , and 8 weeks
Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks , and 8 weeks
Percent Change in Triglycerides From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks , and 8 weeks
Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks, and 8 weeks
Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks , and 8 weeks
Change in Apolipoprotein B From Baseline to Each Observation Point
Time frame: 2 weeks, 4 weeks, and 8 weeks

Results and safety

Results posted to the registry on 13 Apr 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
CI-1038 2.5 mg/5 mg	43	41
CI-1038 2.5 mg/10 mg	41	39
CI-1038 5 mg/5 mg	41	40
CI-1038 5 mg/10 mg	40	38

Primary outcome: Change in Systolic Blood Pressure

Time frame: 8 weeks. Least squares mean (Standard Error). Unit: mm Hg

Measure	CI-1038 2.5 mg/5 mg n = 43	CI-1038 2.5 mg/10 mg n = 41	CI-1038 5 mg/5 mg n = 41	CI-1038 5 mg/10 mg n = 40
Value	-16.6 (1.65)	-15.9 (1.69)	-21.8 (1.69)	-18.9 (1.71)

Population analysed: Full Analysis Set, Last Observation Carried Forward

Primary outcome: Percent Change in Low Density Lipoprotein-Cholesterol

Time frame: 8 weeks. Least squares mean (Standard Error). Unit: Percent Change

Measure	CI-1038 2.5 mg/5 mg n = 43	CI-1038 2.5 mg/10 mg n = 41	CI-1038 5 mg/5 mg n = 41	CI-1038 5 mg/10 mg n = 40
Value	-37.2 (1.49)	-42.5 (1.52)	-34.3 (1.52)	-40.6 (1.54)

Population analysed: Full Analysis Set, Last Observation Carried Forward

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CI-1038 2.5 mg/5 mg	0 of 43 (0%)	6 of 43 (14%)	Not reported
CI-1038 2.5 mg/10 mg	0 of 41 (0%)	7 of 41 (17.1%)	Not reported
CI-1038 5 mg/5 mg	0 of 41 (0%)	8 of 41 (19.5%)	Not reported
CI-1038 5 mg/10 mg	0 of 40 (0%)	8 of 40 (20%)	Not reported

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

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

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 5 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 17 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 13 Apr 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 (time frame: 8 weeks). The study lists 2 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 NCT00530946.

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.