18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
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
1 other identifier
interventional
207
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes
Started May 2008
Shorter than P25 for phase_4 type-2-diabetes
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 9, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
July 2, 2010
CompletedJuly 13, 2010
July 1, 2010
11 months
April 4, 2008
April 21, 2010
July 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
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
week 0 - weeks 3, 6, 9, 12, 15, 18
Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
week 0 - week 12
- +23 more secondary outcomes
Study Arms (1)
aml + olm + hctz
EXPERIMENTALamlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.
Interventions
amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (21)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Sylmar, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Avon, Indiana, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
New Windsor, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Taylors, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Burke, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- James McCarthy
- Organization
- Daiichi Sankyo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 9, 2008
Study Start
May 1, 2008
Primary Completion
April 1, 2009
Study Completion
June 1, 2009
Last Updated
July 13, 2010
Results First Posted
July 2, 2010
Record last verified: 2010-07