DyslipidemiaPhase 4TOGETHERNCT00412113

A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

A Phase 4 study testing Amlodipine besylate and Amlodipine besylate/atorvastatin calcium single pill combination in people with Dyslipidemia and Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 51 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Dyslipidemia, Hypertension
What is being tested?: Amlodipine besylate and Amlodipine besylate/atorvastatin calcium single pill combination
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 245 participants
Where: 51 sitesUnited States
Study dates: Jan 2007to Apr 2008
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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Who cannot join

Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

Pfizer Investigational Site
Auburn, Maine, 04210
Pfizer Investigational Site
Augusta, Georgia, 30904
Pfizer Investigational Site
Belvidere, New Jersey, 07823
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020
Pfizer Investigational Site
Birmingham, Alabama, 35209
Pfizer Investigational Site
Birmingham, Alabama, 35216
Pfizer Investigational Site
Birmingham, Alabama, 35234
Pfizer Investigational Site
Bridgewater, New Jersey, 08807
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Brooklyn, New York, 11229
Pfizer Investigational Site
Buffalo, New York, 14209
Pfizer Investigational Site
Chesapeake, Virginia, 23320
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Clifton, New Jersey, 07013
Pfizer Investigational Site
Dallas, Texas, 75235
Pfizer Investigational Site
Elizabeth, New Jersey, 07202
Pfizer Investigational Site
Erlanger, Kentucky, 41018
Pfizer Investigational Site
Florissant, Missouri, 63031
Pfizer Investigational Site
Gainesville, Florida, 32605
Pfizer Investigational Site
Garden Grove, California, 92843
Pfizer Investigational Site
Goose Creek, South Carolina, 29445
Pfizer Investigational Site
Henderson, Nevada, 89014
Pfizer Investigational Site
Henderson, Nevada, 89015
Pfizer Investigational Site
Hillsborough, New Jersey, 08844
Pfizer Investigational Site
Houston, Texas, 77030-2324
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Kissimmee, Florida, 34741
Pfizer Investigational Site
Lansdale, Pennsylvania, 19446
Pfizer Investigational Site
Melbourne, Florida, 32935
Pfizer Investigational Site
Mesa, Arizona, 85206
Pfizer Investigational Site
Miami, Florida, 33176
Pfizer Investigational Site
Minneapolis, Minnesota, 55404
Pfizer Investigational Site
Mission Viejo, California, 92692
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73103
Pfizer Investigational Site
Omaha, Nebraska, 68116-2004
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19146
Pfizer Investigational Site
Plano, Texas, 75093
Pfizer Investigational Site
Providence, Rhode Island, 02904
Pfizer Investigational Site
Rancho Santa Margarita, California, 92688
Pfizer Investigational Site
Safety Harbor, Florida, 34695
Pfizer Investigational Site
San Antonio, Texas, 78238
Pfizer Investigational Site
South Bend, Indiana, 46601
Pfizer Investigational Site
St. Petersburg, Florida, 33701
Pfizer Investigational Site
Torrance, California, 90502
Pfizer Investigational Site
Trenton, New Jersey, 08618
Pfizer Investigational Site
Tucker, Georgia, 30084
Pfizer Investigational Site
Tulsa, Oklahoma, 74136
Pfizer Investigational Site
Warren, Michigan, 48091

Other trials in United States

About this study

Official title: A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed to Evaluate the Efficacy of an Aggressive Multi-Risk Factor Management Strategy With Caduet (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.

Conditions: Dyslipidemia, Hypertension
Being tested: Amlodipine besylate, Amlodipine besylate/atorvastatin calcium single pill combination
Medical subject headings: Dyslipidemias, Hypertension

What participants receive

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

Amlodipine besylateDrug
Amlodipine besylate 5 mg
Amlodipine besylate/atorvastatin calcium single pill combinationDrug
Amlodipine/atorvastatin single pill combination 10/20 mg
Amlodipine besylateDrug
Amlodipine besylate 10 mg
Amlodipine besylate/atorvastatin calcium single pill combinationDrug
Amlodipine/atorvastatin single pill combination 5/20 mg

Study groups in NCT00412113
Study group	Role	What they receive
Norvasc 5 mg	Active comparator	Blinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks. Receives: Drug: Amlodipine besylate
Caduet 10/20mg	Experimental	Blinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo. Receives: Drug: Amlodipine besylate/atorvastatin calcium single pill combination
Norvasc 10 mg	Active comparator	Blinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks. Receives: Drug: Amlodipine besylate
Caduet 5/20mg	Experimental	Blinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks . Receives: Drug: Amlodipine besylate/atorvastatin calcium single pill combination

What is being measured

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

Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6
Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)
Measured: Week 6
Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk
Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.
Measured: Week 6, baseline

Secondary outcomes (22)

Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4
Subjects achieving both the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC)-7 blood pressure goal of <140/90 mmHg and the National Cholesterol Education Program Adult Treatment Panel (NCEP/ATP) III Update low density lipoprotein-cholesterol (LDL-C) goal <100 mg/dL at Week 4.
Measured: Week 4
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.
Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 4.
Measured: Week 4
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.
Subjects achieving both JNC-7 blood pressure goal of <140/90 mmHg and NCEP/ATP III LDL-C goal <130 mg/dL at Week 6.
Measured: Week 6
Subjects With LDL-C < 100 mg/dL at Week 4
Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 4.
Measured: Week 4
Subjects With LDL-C < 100 mg/dL at Week 6
Subjects Who achieve a goal of LDL-C < 100 mg/dL at Week 6.
Measured: Week 6
Subjects With BP < 140/90 mmHg at Week 4
Subjects achieving BP goal of <140/90 mmHg at week 4
Measured: Week 4
Subjects With BP < 140/90 mmHg at Week 6
Subjects achieving BP goal of <140/90 mmHg at week 6
Measured: Week 6
Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
Mean at observation minus mean at baseline
Measured: Week 4, baseline
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
Mean at observation minus mean at baseline
Measured: Week 4, baseline
Change From Baseline to Week 4 in Pulse Rate
Mean at observation minus mean at baseline measured in beats per minute (bpm).
Measured: Week 4, baseline
Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
Mean change at observation minus mean baseline.
Measured: Week 6, baseline
Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
Change from mean at observation minus mean at baseline
Measured: Week 6, baseline
Change From Baseline to Week 6 in Pulse Rate
Mean at observation minus mean at baseline
Measured: Week 6, baseline
Change From Baseline in LDL at Week 4.
Change: mean of observation minus mean at baseline.
Measured: Week 4, baseline
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
Mean change at observation minus baseline.
Measured: Week 4, baseline
Change in Total Cholesterol (TC) From Baseline to Week 4.
Mean change at observation minus baseline.
Measured: Week 4, baseline
Change From Baseline in Triglycerides (TG) to Week 4.
Mean change at observation minus baseline
Measured: Week 4, baseline
Change From Baseline in LDL at Week 6.
Mean change at observation minus baseline.
Measured: Week 6, baseline
Change From Baseline in HDL at Week 6.
Mean change at observation minus baseline.
Measured: Week 6, baseline
Change From Baseline in Total Cholesterol (TC) to Week 6.
Mean change at observation minus baseline.
Measured: Week 6, baseline
Change From Baseline in Triglycerides (TG) at Week 6.
Mean change at observation minus mean baseline.
Measured: Week 6 , baseline
Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.
Framingham prediction of absolute 10-year risk of CHD outcomes (MI or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol and systolic blood pressure calculated at Week 4. Mean at observation minus mean at baseline.
Measured: Week 4, baseline

Timeline

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

Jan 2007Apr 2008

First posted15 Dec 2006 (estimated)
Study startJan 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 DyslipidemiaStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 245 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00412113
Sponsor's protocol ID: A3841045
Acronym: TOGETHER
Status last verified: Jan 2021
First submitted: 13 Dec 2006
Last updated: 11 Feb 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 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 6-Week, Prospective, Randomized, Double-Blind, Double-Dummy Phase IV Clinical Trial Designed to Evaluate the Efficacy of an Aggressive Multi-Risk Factor Management Strategy With Caduet (A3841045) Versus a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensive Subjects With Additional Risk Factors.
ClinicalTrials.gov ID: NCT00412113
Acronym / sponsor ID: TOGETHER / A3841045
Conditions: Dyslipidemia, Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 245 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: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 15 Dec 2006 (estimated)
Results: Posted 6 Nov 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Norvasc 5 mg	Active comparator	Drug: Amlodipine besylateBlinded amlodipine 5 mg and amlodipine/atorvastatin single pill combination 5/20 mg placebo dosed once daily for 6 weeks.
Caduet 10/20mg	Experimental	Drug: Amlodipine besylate/atorvastatin calcium single pill combinationBlinded amlodipine/atorvastatin single pill combination 10/20 mg dosed once daily for 6 weeks and amlodipine besylate 10 mg placebo.
Norvasc 10 mg	Active comparator	Drug: Amlodipine besylateBlinded amlodipine 19 mg and amlodipine/atorvastatin single pill combination 10/20 mg placebo dosed once daily for 6 weeks.
Caduet 5/20mg	Experimental	Drug: Amlodipine besylate/atorvastatin calcium single pill combinationBlinded amlodipine/atorvastatin single pill combination 5/20 mg and amlodipine besylate 5 mg placebo dosed once daily for 6 weeks .

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Key exclusion criteria (3 listed)

Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, >3 antihypertensive agents (including Norvasc)
Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)

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 besylateAmlodipine besylate 5 mg	Drug	Norvasc 5 mg
Amlodipine besylate/atorvastatin calcium single pill combinationAmlodipine/atorvastatin single pill combination 10/20 mg	Drug	Caduet 10/20mg
Amlodipine besylateAmlodipine besylate 10 mg	Drug	Norvasc 10 mg
Amlodipine besylate/atorvastatin calcium single pill combinationAmlodipine/atorvastatin single pill combination 5/20 mg	Drug	Caduet 5/20mg

Primary outcome

Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6
Time frame: Week 6
Number of subjects reaching dual goal of systolic blood pressure <140 millimeters of mercury (mmHg) and diastolic blood pressue of <90 mmHg and low density lipoprotein-cholesterol(LDL-C) <100 milligrams per deciliter(mg/dL)
Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk
Time frame: Week 6, baseline
Framingham prediction of absolute 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) are calculations based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) of subject age, sex, current blood pressure treatment status, current smoking status, total cholesterol, high-density lipoprotein cholesterol, and systolic blood pressure calculated at Week 6. Mean at observation minus mean at baseline.

22 secondary outcomes

Subjects With Blood Pressure of <140/90 mmHg and LDL-C <100 mg/dL at Week 4
Time frame: Week 4
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 4.
Time frame: Week 4
Subjects With BP <140/90 mmHg and LDL-C <130 mg/dL at Week 6.
Time frame: Week 6
Subjects With LDL-C < 100 mg/dL at Week 4
Time frame: Week 4
Subjects With LDL-C < 100 mg/dL at Week 6
Time frame: Week 6
Subjects With BP < 140/90 mmHg at Week 4
Time frame: Week 4
Subjects With BP < 140/90 mmHg at Week 6
Time frame: Week 6
Change From Baseline to Week 4 in Systolic Blood Pressure (SBP).
Time frame: Week 4, baseline
Change From Baseline to Week 4 in Diastolic Blood Pressure (DBP)
Time frame: Week 4, baseline
Change From Baseline to Week 4 in Pulse Rate
Time frame: Week 4, baseline
Change From Baseline to Week 6 in Systolic Blood Pressure (SBP)
Time frame: Week 6, baseline
Change From Baseline to Week 6 in Diastolic Blood Pressue (DBP)
Time frame: Week 6, baseline
Change From Baseline to Week 6 in Pulse Rate
Time frame: Week 6, baseline
Change From Baseline in LDL at Week 4.
Time frame: Week 4, baseline
Change From Baseline in High Density Lipoprotein (HDL) at Week 4.
Time frame: Week 4, baseline
Change in Total Cholesterol (TC) From Baseline to Week 4.
Time frame: Week 4, baseline
Change From Baseline in Triglycerides (TG) to Week 4.
Time frame: Week 4, baseline
Change From Baseline in LDL at Week 6.
Time frame: Week 6, baseline
Change From Baseline in HDL at Week 6.
Time frame: Week 6, baseline
Change From Baseline in Total Cholesterol (TC) to Week 6.
Time frame: Week 6, baseline
Change From Baseline in Triglycerides (TG) at Week 6.
Time frame: Week 6 , baseline
Change From Baseline to Week 4 in Framingham Predicted Absolute 10-year Risk.
Time frame: Week 4, baseline

Results and safety

Results posted to the registry on 6 Nov 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
Norvasc + TLC	123	111
Caduet + TLC	122	107

Primary outcome: Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6

Time frame: Week 6. Number. Unit: participants

Measure	Norvasc + TLC n = 115	Caduet + TLC n = 118
Value	11	80

Norvasc + TLC vs Caduet + TLC: Odds Ratio (OR): 19.03 (95% CI 9.14 to 39.63), p <0.001, Cochran-Mantel-Haenszel

Population analysed: Full analysis set (FAS) is all randomized subjects who take at least one dose of study drug and and have any post-baseline efficacy assessments.

Primary outcome: Change From Baseline to Week 6 in Framingham Predicted Absolute 10-year Risk

Time frame: Week 6, baseline. Least squares mean (Standard Deviation). Unit: score on scale

Measure	Norvasc + TLC n = 115	Caduet + TLC n = 118
Value	-0.1 (2.9)	-2.9 (3.0)

Norvasc + TLC vs Caduet + TLC: Difference in LS Means: -2.8 (95% CI -3.5 to -2.1), p <0.001, ANCOVA

Population analysed: The full analysis set of all randomized subjects who took at least one dose of study drug and had any post-baseline efficacy assessment

22 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Norvasc + TLC	0 of 122 (0%)	16 of 122 (13.1%)	Not reported
Caduet + TLC	0 of 122 (0%)	7 of 122 (5.7%)	Not reported

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.

Related trials for Dyslipidemia

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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

51 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 1 inclusion and 3 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 51 sites in United States. 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 6 Nov 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?

Subjects With Blood Pressure (BP) <140/90 Millimeters of Mercury (mmHg) and Low Density Lipoprotein Cholesterol (LDL-C) <100 Milligrams Per Deciliter(mg/dL) at Week 6 (time frame: Week 6). 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 NCT00412113.

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.