Type 2 DiabetesPhase 4NCT00654745

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

A Phase 4 study testing Amlodipine, amlodipine / olmesartan medoxomil combination and Hydrochlorothiazide in people with Type 2 Diabetes and Hypertension, run by Daiichi Sankyo at 21 sites in United States.

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 determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Type 2 Diabetes, Hypertension
What is being tested?: Amlodipine, amlodipine / olmesartan medoxomil combination and Hydrochlorothiazide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 207 participants
Where: 21 sitesUnited States
Study dates: May 2008to Jun 2009
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged 18 to 80 years.
Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);
Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below:
Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or
Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or
Two-hour plasma glucose >=200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test;

Show all 9Show fewer

Newly diagnosed hypertension or uncontrolled hypertension (defined as SBP >130 mmHg and/or DBP >80 mmHg) on current antihypertensive monotherapy or combination therapy.
Subjects must fulfill mean seated office blood pressure parameters at two consecutive, qualifying visits during the placebo run-in phase, and, subsequently, daytime ambulatory blood pressure monitoring (ABPM) criteria.
Females should not be pregnant or lactating and, if applicable, using adequate contraception.

Who cannot join

Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at screening;
Subjects with type 1 or type 2 diabetes mellitus requiring insulin.
Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary hypertension.

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Study site
Aventura, Florida
Study site
Avon, Indiana
Study site
Burke, Virginia
Study site
Charleston, South Carolina
Study site
Cincinnati, Ohio
Study site
Dallas, Texas
Study site
DeLand, Florida
Study site
Greer, South Carolina
Study site
Hialeah, Florida
Study site
Indianapolis, Indiana
Study site
Las Vegas, Nevada
Study site
Los Angeles, California
Study site
Nashville, Tennessee
Study site
New Windsor, New York
Study site
Oklahoma City, Oklahoma
Study site
Pembroke Pines, Florida
Study site
San Antonio, Texas
Study site
Sylmar, California
Study site
Taylors, South Carolina
Study site
Tustin, California
Study site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Prospective, Open-label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Read the detailed description

This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

Conditions: Type 2 Diabetes, Hypertension
Being tested: Amlodipine, amlodipine / olmesartan medoxomil combination, Hydrochlorothiazide
Keywords: blood pressure reduction
Medical subject headings: Diabetes Mellitus, Type 2, Hypertension

What participants receive

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

AmlodipineDrug
Also called Norvasc
Amlodipine 5 mg tablets , Daily for 3 weeks;
amlodipine / olmesartan medoxomil combinationDrug
Also called Azor
amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg
HydrochlorothiazideDrug
hydrochlorothiazide tablets, 12.5 mg or 25 mg.

Study groups in NCT00654745
Study group	Role	What they receive
aml + olm + hctz	Experimental	amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required. Receives: Drug: Amlodipine; Drug: amlodipine / olmesartan medoxomil combination; Drug: Hydrochlorothiazide

What is being measured

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

Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.
Measured: week 0 - week 12

Secondary outcomes (28)

Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP
Measured: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP
Measured: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Measured: week 0 - weeks 3, 6, 9, 12, 15, 18
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
Measured: week 0 - weeks 3, 6, 9, 12, 15, 18
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
number of participants achieving mean daytime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
number of participants achieving mean nighttime ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, BP<120/70, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75, DBP<70 at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Measured: week 0 - week 12
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 3
Measured: week 0 - week 3
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 6
Measured: week 0 - week 6
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 9
Measured: week 0 - week 9
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 12
Measured: week 0 - week 12
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 15
Measured: week 0 - week 15
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
number of participants achieving seated systolic and diastolic blood pressure thresholds BP<135/85, BP<130/80, BP<125/75, BP<120/80, SBP<135, SBP<130, SBP<125, SBP<120, DBP<85, DBP<80, DBP<75 at week 18
Measured: week 0 - week 18
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 3
Measured: week 0 - week 3
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 6
Measured: week 0 - week 6
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 9
Measured: week 0 - week 9
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 12
Measured: week 0 - week 12
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 15
Measured: week 0 - week 15
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction <= 15 mmHg, SBP reduction > 15 mmHg \& <= 30 mmHg, SBP reduction > 30 mmHg \& <= 45 mmHg, SBP reduction > 45 mmHg, DBP reduction <= 10 mmHg, DBP reduction > 10 mmHg \& <= 15 mmHg, DBP reduction > 15 mmHg \& <= 20 mmHg, DBP reduction > 20 mmHg at week 18
Measured: week 0 - week 18

Timeline

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

May 2008Jun 2009

First posted9 Apr 2008 (estimated)
Study startMay 2008
Primary completionApr 2009
Study completionJun 2009

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 Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe 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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 207 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654745
Sponsor's protocol ID: CS-8663-403
Status last verified: Jul 2010
First submitted: 4 Apr 2008
Last updated: 13 Jul 2010
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?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open-label, Ambulatory Blood Pressure Monitoring (ABPM) Dose Titration Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil and Amlodipine Based Treatment Regimen in Hypertensive, Type 2 Diabetic Subjects
ClinicalTrials.gov ID: NCT00654745
Acronym / sponsor ID: CS-8663-403
Conditions: Type 2 Diabetes, Hypertension
Keywords: blood pressure reduction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 207 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Apr 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 9 Apr 2008 (estimated)
Results: Posted 2 Jul 2010

Clinical summary

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

To determine if olmesartan plus amlodipine combination therapy alone and with hydrochlorothiazide will be safe and effective to reduce high blood pressure in hypertensive, type 2 diabetic subjects.

Detailed description

This is a single group study in which participants were titrated to the next of 6 regimens if blood pressure (BP) goals were not met.

Study design

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

Arm	Type	Receives
aml + olm + hctz	Experimental	Drug: Amlodipine, Drug: amlodipine / olmesartan medoxomil combination, Drug: Hydrochlorothiazideamlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Males or females aged 18 to 80 years.
Diagnosis of type 2 diabetes mellitus and on a stable regimen of any oral antidiabetic agent(s) for at least 3 months, with or without adjunctive use of Byetta (exenatide);
Note: Subjects diagnosed with type 2 diabetes mellitus who were not on oral antidiabetic agents may have been enrolled if they had a documented history of type 2 diabetes by American Diabetes Association criteria, including the specific plasma glucose results listed below:
Fasting plasma glucose >=126 mg/dL (7.0 mmol/L); or
Symptoms of hyperglycemia and a casual (any time of day without regard to time since last meal) plasma glucose >=200 mg/dL (11.1 mmol/L). The classic symptoms of hyperglycemia were considered to include polyuria, polydipsia, and unexplained weight loss; or

Key exclusion criteria (4 listed)

Subjects with uncontrolled hypertension taking multiple antihypertensive therapies (at the discretion of the investigator).
Type 2 diabetes mellitus with a glycosylated hemoglobin A1c (HbA1c) >=9.0% at screening;
Subjects with type 1 or type 2 diabetes mellitus requiring insulin.
Subjects with any serious disorder which may limit the ability to evaluate the safety and efficacy of study medication, or subjects with secondary 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
AmlodipineAlso: NorvascAmlodipine 5 mg tablets , Daily for 3 weeks;	Drug	aml + olm + hctz
amlodipine / olmesartan medoxomil combinationAlso: Azoramlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg	Drug	aml + olm + hctz
Hydrochlorothiazidehydrochlorothiazide tablets, 12.5 mg or 25 mg.	Drug	aml + olm + hctz

Primary outcome

Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment
Time frame: week 0 - week 12
Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0.

28 secondary outcomes

Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
Time frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
Time frame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
Time frame: week 0 - weeks 3, 6, 9, 12, 15, 18
Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
Time frame: week 0 - weeks 3, 6, 9, 12, 15, 18
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
Time frame: week 0 - week 3
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
Time frame: week 0 - week 6
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
Time frame: week 0 - week 9
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
Time frame: week 0 - week 15
Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
Time frame: week 0 - week 18
Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
Time frame: week 0 - week 12
Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
Time frame: week 0 - week 3
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
Time frame: week 0 - week 6
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
Time frame: week 0 - week 9
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
Time frame: week 0 - week 12
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
Time frame: week 0 - week 15
Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
Time frame: week 0 - week 18

Results and safety

Results posted to the registry on 2 Jul 2010, 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, Olmesartan Medoxomil, Hydrochlorothiazide	207	164

Primary outcome: Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment

Time frame: week 0 - week 12. Mean (Standard Error). Unit: mm Hg

Measure	Aml + Olm + Hctz n = 165
Value	-19.9 (0.76)

Aml + Olm + Hctz: Mean Difference (Net): -19.9 (95% CI -21.5 to -18.4), p <0.0001, t-test, 2 sided

Population analysed: ABPM subjects analysis population included 165 subjects who received at least one dose of active study medication and provided valid ambulatory blood pressure monitoring measurements at baseline and week 12.

28 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
ALL - Aml + Olm + Hctz	4 of 207 (1.9%)	80 of 207 (38.6%)	Not reported
Start - Amlodipine 5 mg	0 of 207 (0%)	16 of 207 (7.7%)	Not reported
Titration 1 - Amlodipine 5 mg / Olmesartan 20 mg	0 of 195 (0%)	15 of 195 (7.7%)	Not reported
Titration 2 - Amlodipine 5 mg / Olmesartan 40 mg	1 of 177 (0.6%)	10 of 177 (5.6%)	Not reported
Titration 3 - Amlodipine 10 mg / Olmesartan 40 mg	0 of 167 (0%)	21 of 167 (12.6%)	Not reported
Titration 4 Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 12.5 mg	1 of 146 (0.7%)	14 of 146 (9.6%)	Not reported
Titration 5 - Amlodipine 10 mg / Olmesartan 40 mg / HCTZ 25 mg	2 of 101 (2%)	4 of 101 (4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

21 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 9 inclusion and 4 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 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 2 Jul 2010). 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 From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment (time frame: week 0 - week 12). 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 NCT00654745.

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 13 Jul 2010.