18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes; Hypertension
Intervention: Amlodipine (Drug); amlodipine / olmesartan medoxomil combination (Drug); Hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Secondary outcome: Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active TreatmentChange From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12 Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12 Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12 Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12 Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12 Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at 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 at 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 at 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 at Week 18 Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 Number of Participants Achieving Mean Nighttime 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 at Week 12 Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at 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 at 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 at 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 at Week 18
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Los Angeles, California, United States
Sylmar, California, United States
Tustin, California, United States
Aventura, Florida, United States
DeLand, Florida, United States
Hialeah, Florida, United States
Pembroke Pines, Florida, United States
Avon, Indiana, United States
Indianapolis, Indiana, United States
Las Vegas, Nevada, United States
New Windsor, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
Taylors, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Burke, Virginia, United States
Additional Information
Starting date: May 2008
Last updated: July 9, 2010
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