Clinical trial NCT00654745: 18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Hypertension
Keywords: blood pressure reduction
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
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
timeFrame: week 0 - week 12
Secondary outcomes:
measure: Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment
timeFrame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
measure: Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment
timeFrame: week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)
measure: Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
timeFrame: week 0 - weeks 3, 6, 9, 12, 15, 18
measure: Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks
timeFrame: week 0 - weeks 3, 6, 9, 12, 15, 18
measure: Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3
timeFrame: week 0 - week 3
measure: Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6
timeFrame: week 0 - week 6
measure: Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9
timeFrame: week 0 - week 9
measure: Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15
timeFrame: week 0 - week 15
measure: Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18
timeFrame: week 0 - week 18
measure: Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3
timeFrame: week 0 - week 3
measure: Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6
timeFrame: week 0 - week 6
measure: Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9
timeFrame: week 0 - week 9
measure: Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12
timeFrame: week 0 - week 12
measure: Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15
timeFrame: week 0 - week 15
measure: Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18
timeFrame: week 0 - week 18
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Sylmar
country: United States
state: California
city: Tustin
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Avon
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Las Vegas
country: United States
state: Nevada
city: New Windsor
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Taylors
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
Study officials:
References: