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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00654745
First received: April 4, 2008
Last updated: July 9, 2010
Last verified: July 2010

April 4, 2008
July 9, 2010
May 2008
April 2009   (final data collection date for 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 ] [ Designated as safety issue: No ]
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.
Change from baseline in mean 24-hour ABPM SBP after 12 weeks of active treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00654745 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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
  • 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) ] [ Designated as safety issue: No ]
    Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP
  • 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 ] [ Designated as safety issue: No ]
    change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 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 ] [ Designated as safety issue: No ]
    change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18.
  • Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3 [ Time Frame: week 0 - week 3 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6 [ Time Frame: week 0 - week 6 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9 [ Time Frame: week 0 - week 9 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15 [ Time Frame: week 0 - week 15 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18 [ Time Frame: week 0 - week 18 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3 [ Time Frame: week 0 - week 3 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6 [ Time Frame: week 0 - week 6 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9 [ Time Frame: week 0 - week 9 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12 [ Time Frame: week 0 - week 12 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15 [ Time Frame: week 0 - week 15 ] [ Designated as safety issue: No ]
    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
  • Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18 [ Time Frame: week 0 - week 18 ] [ Designated as safety issue: No ]
    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
Change from baseline in mean 24-hour ABPM DBP after 12 weeks of active treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Hypertension
  • Drug: Amlodipine
    Amlodipine 5 mg tablets , Daily for 3 weeks;
    Other Name: Norvasc
  • Drug: amlodipine / olmesartan medoxomil combination
    amlodipine / olmesartan medoxomil combination tablets 5 mg/20 mg or 5 mg/40 mg or 10 mg/40 mg
    Other Name: Azor
  • Drug: Hydrochlorothiazide
    hydrochlorothiazide tablets, 12.5 mg or 25 mg.
Experimental: aml + olm + hctz
amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.
Interventions:
  • Drug: Amlodipine
  • Drug: amlodipine / olmesartan medoxomil combination
  • Drug: Hydrochlorothiazide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
June 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00654745
CS-8663-403
No
Director, Medical Research, Hypertension, Daiichi Sankyo Inc.
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP