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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Hypertension
Drug: Amlodipine
Drug: amlodipine / olmesartan medoxomil combination
Drug: Hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 207
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aml + olm + hctz
amlodipine; and olmesartan medoxomil, if required; and hydrochlorothiazide, if required.
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.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654745

Locations
United States, California
Los Angeles, California, United States
Sylmar, California, United States
Tustin, California, United States
United States, Florida
Aventura, Florida, United States
DeLand, Florida, United States
Hialeah, Florida, United States
Pembroke Pines, Florida, United States
United States, Indiana
Avon, Indiana, United States
Indianapolis, Indiana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
New Windsor, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, South Carolina
Charleston, South Carolina, United States
Greer, South Carolina, United States
Taylors, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Burke, Virginia, United States
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Director, Medical Research, Hypertension, Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00654745     History of Changes
Other Study ID Numbers: CS-8663-403
Study First Received: April 4, 2008
Results First Received: April 21, 2010
Last Updated: July 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
blood pressure reduction

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hypertension
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Olmesartan medoxomil
Olmesartan
Hydrochlorothiazide
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 19, 2014