Phase 4
Completed N=207
18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
Source: ClinicalTrials.gov NCT00654745 ↗Enrolled (actual)
207
Serious AEs
0.7%
Results posted
Jul 2010
Primary outcomePrimary: Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment — -19.9 mm Hg — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment |
-19.9 | <0.0001 sig |
| SECONDARY Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment |
-11.2; -11.7; -10.4; -10.9; -11.1; -11.5 | <0.0001 sig |
| SECONDARY Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment |
-20.8; -18.5; -18.9; -19.1; -19.5 | <0.0001 sig |
| SECONDARY Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks |
-10.3; -17.9; -20.0; -23.7; -28.5; -31.1 | <0.0001 sig |
| SECONDARY Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks |
-4.1; -8.2; -9.7; -11.2; -14.4; -15.1 | <0.0001 sig |
| SECONDARY Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12 |
140; 116; 76; 59; 140; 120 | — |
| SECONDARY Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12 |
116; 83; 48; 42; 118; 94 | — |
| SECONDARY Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12 |
152; 137; 119; 112; 101; 154 | — |
| SECONDARY Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12 |
135; 124; 101; 85; 143; 127 | — |
| SECONDARY Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12 |
129; 107; 92; 72; 131; 114 | — |
| SECONDARY Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12 |
110; 85; 63; 49; 115; 92 | — |
| SECONDARY Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3 |
31; 10; 4; 2; 41; 17 | — |
| SECONDARY Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6 |
61; 36; 18; 13; 73; 48 | — |
| SECONDARY Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9 |
76; 47; 25; 19; 82; 61 | — |
| SECONDARY Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12 |
86; 61; 33; 28; 93; 70 | — |
| SECONDARY Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15 |
114; 83; 51; 45; 116; 95 | — |
| SECONDARY Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18 |
117; 87; 56; 49; 123; 101 | — |
| SECONDARY Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 |
50; 91; 22; 2; 72; 47 | — |
| SECONDARY Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 |
47; 84; 31; 3; 68; 41 | — |
| SECONDARY Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 |
60; 79; 21; 5; 80; 41 | — |
| SECONDARY Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 |
61; 76; 23; 5; 76; 41 | — |
| SECONDARY Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions |
67; 65; 28; 5; 76; 36 | — |
| SECONDARY Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 |
63; 62; 35; 5; 77; 28 | — |
| SECONDARY Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3 |
131; 62; 6; 2; 163; 25 | — |
| SECONDARY Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6 |
69; 90; 31; 2; 120; 33 | — |
| SECONDARY Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9 |
72; 69; 34; 9; 100; 43 | — |
| SECONDARY Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12 |
48; 73; 45; 11; 85; 42 | — |
| SECONDARY Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15 |
31; 66; 55; 20; 52; 45 | — |
| SECONDARY Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18 |
22; 53; 64; 25; 50; 33 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00654745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.