HypertensionPhase 3NCT01496430
Efficacy and Safety of Azilsartan Medoxomil Used in Combination With Metformin in Participants With Hypertension and Diabetes
A Phase 3 study testing Azilsartan medoxomil in people with Hypertension and Diabetes, run by Takeda at 68 sites in United States.
Trial summary
The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes
- What is being tested?
- Azilsartan medoxomil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 68 sitesUnited States
- Study dates
- Jan 2012to May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Was male or female and ≥18 years.
- Had type 2 diabetes mellitus with HbA1c of ≥7.5 to ≤9.5% at Screening.
- Was treated with metformin alone (no treatment with any antidiabetic agents other than metformin within the 3 months prior to Screening) and was experiencing inadequate glycemic control. The participant should have received metformin monotherapy for ≥8 weeks prior to Screening at a stable dose ≥1500 mg). Participants with a maximum tolerated dose (MTD) that was documented to be less than 1500 mg of metformin could also be enrolled if this dose had been stable for 8 weeks prior to Screening.
- Was treated with antihypertensive therapy and had a mean, trough, sitting clinic systolic blood pressure (SBP) ≥135 and < 160 mm Hg on Day -1 (after washout of prior antihypertensive therapy) or the participant had not received antihypertensive treatment within 28 days before Screening and had a mean sitting clinic SBP ≥135 and < 160 mm Hg at the Screening Visit and on Day -1.
- Had clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or results that were deemed not clinically significant in this participant population for inclusion in this study, by the investigator.
Who cannot join
- Had a mean, trough, sitting clinic diastolic blood pressure (DBP) ≥ 100 mm Hg at Day -1.
- Had type 1 or poorly controlled type 2 diabetes mellitus (HbA1c >9.5%) at Screening.
- Was taking or expected to take an excluded medication.
- Had a history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
- Had clinically significant cardiac conduction defects (for example, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation).
- Had hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease.
Show all 13Show fewer
- Had secondary hypertension of any etiology (e.g., renovascular disease, pheochromocytoma, Cushing's syndrome).
- Had renal dysfunction defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at Screening.
- Had albuminuria defined as >200 mg/g at Screening.
- Had known or suspected unilateral or bilateral renal artery stenosis.
- Had unexplained microhematuria ≥3 RBCs/HPF or macrohematuria at Screening and confirmed on repeat testing.
- Treatment with antidiabetic agents (sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides, thiazolidinediones (TZDs), and/or insulin) other than metformin during the 3 months prior to Screening.
- Had hyperkalemia as defined by central laboratory normal reference range at Screening.
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
United States68 sites
Study site
Albuquerque, New Mexico
Study site
Anderson, South Carolina
Study site
Avon, Indiana
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Bradenton, Florida
Study site
Brooklyn, New York
Study site
Brooksville, Florida
Study site
Buena Park, California
Study site
Burke, Virginia
Study site
Calabash, North Carolina
Study site
Centerville, Ohio
Study site
Chattanooga, Tennessee
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbia, Missouri
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Downingtown, Pennsylvania
Study site
Evergreen Park, Illinois
Study site
Fleetwood, Pennsylvania
Study site
Green Valley, Arizona
Study site
Greenfield, Indiana
Study site
Greensboro, North Carolina
Study site
Gurnee, Illinois
Study site
Hallandale, Florida
Study site
Hawaiian Gardens, California
Study site
Houston, Texas
Study site
Irving, Texas
Study site
Jupiter, Florida
Study site
Kingsport, Tennessee
Study site
Las Vegas, Nevada
Study site
Lenoir, North Carolina
Study site
Lexington, Kentucky
Study site
Manassas, Virginia
Study site
Margate City, New Jersey
Study site
Miami, Florida
Study site
Morehead City, North Carolina
Study site
Nashville, Tennessee
Study site
North Richland Hills, Texas
Study site
Norwalk, California
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Orlando, Florida
Study site
Paducah, Kentucky
Study site
Paramount, California
Study site
Pearland, Texas
Study site
Pembroke Pines, Florida
Study site
Providence, Rhode Island
Study site
Rancho Cucamonga, California
Study site
Reading, Pennsylvania
Study site
Richmond, Virginia
Study site
Roswell, Georgia
Study site
Sacramento, California
Study site
Salisbury, North Carolina
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
St. Petersburg, Florida
Study site
Tampa, Florida
Study site
Tempe, Arizona
Study site
Tucson, Arizona
Study site
Tustin, California
Study site
Virginia Beach, Virginia
Study site
Wauwatosa, Wisconsin
Study site
Wilmington, North Carolina
Study site
Winston-Salem, North Carolina
Study site
Winter Park, Florida
About this study
Official title: A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of TAK-491 Compared to Placebo When Used in Combination With Metformin in Subjects With Hypertension and Type 2 Diabetes
The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.
Read the detailed description
The study included a Screening Period of up to 4 weeks, which coincided with a 2-week single-blind, placebo Run-in Period, a 24 week Treatment Period, and a 2-week Follow-up Period. The duration of the study was approximately 30 weeks. The planned number of participants (n=450) was not reached; actual enrollment consisted of 105 particpants. Due to low enrollment this study was terminated early by Takeda.
- Conditions
- Hypertension, Diabetes
- Being tested
- Placebo, Azilsartan medoxomil
- Keywords
- Drug Therapy, Hypertension and Diabetes
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Azilsartan medoxomilDrug
Also called TAK-491
Azilsartan medoxomilDrug
Also called TAK-491
| Study group | Role | What they receive |
|---|---|---|
| Placebo QD | Placebo comparator | Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks. Receives: Drug: Placebo |
| Azilsartan Medoxomil 40 mg QD | Experimental | Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks. Receives: Drug: Azilsartan medoxomil |
| Azilsartan Medoxomil 80 mg QD | Experimental | Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks. Receives: Drug: Azilsartan medoxomil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure
The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
Measured: Baseline and Week 8
Secondary outcomes (22)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.
Measured: Baseline and Week 24
Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure
The change in trough diastolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.
Measured: Baseline and Week 8
Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Measured: Baseline and Week 8
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.
Measured: Baseline and Week 8
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in daytime (6am to 10pm) mean systolic blood pressure measured week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Measured: Baseline and Week 8
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.
Measured: Baseline and Week 8
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Measured: Baseline and Week 8
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.
Measured: Baseline and Week 8
Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.
Measured: Baseline and Week 8
Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.
Measured: Baseline and Week 8
Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
The change in trough systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Measured: Baseline and Week 8
Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
The change in trough diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Measured: Baseline and Week 8
Percentage of Participants Requiring Rescue Glycemic Therapy
Percentage of participants requiring rescue glycemic therapy during study.
Measured: 24 Weeks
Time to First Glycemic Rescue
The time to the first instance of participants requiring glycemic rescue during study.
Measured: 24 Weeks
Change From Baseline in HbA1c
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.
Measured: Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20
Change From Baseline in Fasting Plasma Glucose
The change between the fasting plasma glucose value collected at each week indicated relative to baseline.
Measured: Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)
The change between the glucose value collected at weeks 6 and 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Measured: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT
The change between the AUC for glucose at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Measured: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT
The change between the AUC for insulin at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Measured: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT
The change between the AUC for C-peptide at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Measured: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT
The change between the AUC for insulin/glucose ratio at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Measured: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT
The change between the AUC for glucagon at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.
Measured: Baseline and Weeks 6 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Business Decision; No Safety Or Efficacy Concerns. (See below)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496430
- Sponsor's protocol ID
- TAK-491_304
- Other IDs
- U1111-1125-1197
- Status last verified
- Apr 2015
- First submitted
- 18 Dec 2011
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase 3b Proof-of-Concept Study to Evaluate the Efficacy and Safety of TAK-491 Compared to Placebo When Used in Combination With Metformin in Subjects With Hypertension and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01496430
- Acronym / sponsor ID
- TAK-491_304
- Conditions
- Hypertension, Diabetes
- Keywords
- Drug Therapy, Hypertension and Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision; No Safety Or Efficacy Concerns. (See below)
- Enrolment
- 105 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Posted 6 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the antihypertensive and antiglycemic effects, as well as the safety and tolerability of TAK-491 (azilsartan medoxomil), once daily (QD), in stage 1 hypertensive, type 2 diabetes mellitus (T2DM) participants whose glycemic control was inadequate on metformin alone.
Detailed description
The study included a Screening Period of up to 4 weeks, which coincided with a 2-week single-blind, placebo Run-in Period, a 24 week Treatment Period, and a 2-week Follow-up Period. The duration of the study was approximately 30 weeks. The planned number of participants (n=450) was not reached; actual enrollment consisted of 105 particpants. Due to low enrollment this study was terminated early by Takeda.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo QD | Placebo comparator | Drug: PlaceboAzilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks. |
| Azilsartan Medoxomil 40 mg QD | Experimental | Drug: Azilsartan medoxomilAzilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks. |
| Azilsartan Medoxomil 80 mg QD | Experimental | Drug: Azilsartan medoxomilAzilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Was male or female and ≥18 years.
- Had type 2 diabetes mellitus with HbA1c of ≥7.5 to ≤9.5% at Screening.
- Was treated with metformin alone (no treatment with any antidiabetic agents other than metformin within the 3 months prior to Screening) and was experiencing inadequate glycemic control. The participant should have received metformin monotherapy for ≥8 weeks prior to Screening at a stable dose ≥1500 mg). Participants with a maximum tolerated dose (MTD) that was documented to be less than 1500 mg of metformin could also be enrolled if this dose had been stable for 8 weeks prior to Screening.
- Was treated with antihypertensive therapy and had a mean, trough, sitting clinic systolic blood pressure (SBP) ≥135 and < 160 mm Hg on Day -1 (after washout of prior antihypertensive therapy) or the participant had not received antihypertensive treatment within 28 days before Screening and had a mean sitting clinic SBP ≥135 and < 160 mm Hg at the Screening Visit and on Day -1.
- Had clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or results that were deemed not clinically significant in this participant population for inclusion in this study, by the investigator.
Key exclusion criteria (13 listed)
- Had a mean, trough, sitting clinic diastolic blood pressure (DBP) ≥ 100 mm Hg at Day -1.
- Had type 1 or poorly controlled type 2 diabetes mellitus (HbA1c >9.5%) at Screening.
- Was taking or expected to take an excluded medication.
- Had a history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.
- Had clinically significant cardiac conduction defects (for example, 3rd degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Drug | Placebo QD |
| Azilsartan medoxomilAlso: TAK-491 | Drug | Azilsartan Medoxomil 40 mg QD |
| Azilsartan medoxomilAlso: TAK-491 | Drug | Azilsartan Medoxomil 80 mg QD |
Primary outcome
Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure
Time frame: Baseline and Week 8
The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.
22 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and Week 24
Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure
Time frame: Baseline and Week 8
Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Time frame: Baseline and Week 8
Percentage of Participants Requiring Rescue Glycemic Therapy
Time frame: 24 Weeks
Time to First Glycemic Rescue
Time frame: 24 Weeks
Change From Baseline in HbA1c
Time frame: Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24
Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)
Time frame: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT
Time frame: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT
Time frame: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT
Time frame: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT
Time frame: Baseline and Weeks 6 and 24
Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT
Time frame: Baseline and Weeks 6 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director, Clinical Science study director
Takeda
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azilsartan medoxomil in people with Hypertension and Diabetes, run by Takeda at 68 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.