Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension
This study has been completed.
Sponsor:
Takeda Pharmaceutical Company Limited
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT01289132
First received: February 1, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
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Purpose
The purpose of this study was to evaluate the dose-response relationships of azilsartan, once daily (QD) in participants with mild to moderate uncomplicated essential hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: Placebo Drug: Azilsartan Drug: Candesartan cilexetil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study of the Efficacy, Safety and Tolerability of TAK-536 in Subjects With Mild to Moderate Uncomplicated Essential Hypertension |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]The change between sitting trough clinic diastolic blood pressure measured at week 12 or final visit from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Secondary Outcome Measures:
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 2). [ Time Frame: Baseline and Week 2. ] [ Designated as safety issue: No ]The change between sitting trough clinic diastolic blood pressure measured at week 2 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 4). [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]The change between sitting trough clinic diastolic blood pressure measured at week 4 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 6). [ Time Frame: Baseline and Week 6. ] [ Designated as safety issue: No ]The change between sitting trough clinic diastolic blood pressure measured at week 6 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 8). [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]The change between sitting trough clinic diastolic blood pressure measured at week 8 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 10). [ Time Frame: Baseline and Week 10. ] [ Designated as safety issue: No ]The change between sitting trough clinic diastolic blood pressure measured at week 10 from diastolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 2). [ Time Frame: Baseline and Week 2. ] [ Designated as safety issue: No ]The change between sitting trough clinic systolic blood pressure measured at week 2 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 4). [ Time Frame: Baseline and Week 4. ] [ Designated as safety issue: No ]The change between sitting trough clinic systolic blood pressure measured at week 4 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 6). [ Time Frame: Baseline and Week 6. ] [ Designated as safety issue: No ]The change between sitting trough clinic systolic blood pressure measured at week 6 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 8). [ Time Frame: Baseline and Week 8. ] [ Designated as safety issue: No ]The change between sitting trough clinic systolic blood pressure measured at week 8 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 10). [ Time Frame: Baseline and Week 10. ] [ Designated as safety issue: No ]The change between sitting trough clinic systolic blood pressure measured at week 10 from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 12). [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]The change between sitting trough clinic systolic blood pressure measured at week 12 or final visit from systolic blood pressure measured at baseline. Trough is a time point immediately before the next administration where drug blood concentration is lowest. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
- Number of Participants with a ≥20 mmHg Decrease in Sitting Trough Systolic Blood Pressure and a ≥10 mmHg Decrease in Sitting Trough Diastolic Blood Pressure. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]Number of participants designated as responders who have a ≥20 mmHg Decrease in sitting trough systolic blood pressure and a ≥10 mmHg Decrease in sitting trough diastolic blood pressure at week 12 or final visit from baseline.
- Number of Participants with a Sitting Trough Systolic Blood Pressure of <130 mmHg and a Sitting Trough Diastolic Blood Pressure of <85 mmHg. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]Number of participants designated as responders with a sitting trough systolic blood pressure of <130 mmHg and a sitting trough diastolic blood pressure of <85 mmHg at week 12 or final visit from baseline.
- Incidence of Adverse Events. [ Time Frame: On occurrence (up to Week 12). ] [ Designated as safety issue: Yes ]Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
- Change from Baseline in Supine Systolic Blood Pressure. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The change between supine systolic blood pressure measured at week 12 or final visit from baseline. Supine systolic blood pressure is measured in participants laying on their back in a face-up position once after resting for 2 minutes.
- Change from Baseline in Supine Diastolic Blood Pressure. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The change between supine diastolic blood pressure measured at week 12 or final visit from baseline. Supine diastolic blood pressure is measured in participants laying on their back in a face-up position once after resting for 2 minutes.
- Change from Baseline in Standing Systolic Blood Pressure. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The change between standing systolic blood pressure measured at week 12 or final visit from baseline. Standing systolic blood pressure is measured once after participants keep a standing position for 1 minute.
- Change from Baseline in Standing Diastolic Blood Pressure. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The change between standing diastolic blood pressure measured at week 12 or final visit from baseline. Standing diastolic blood pressure is measured once after participants keep a standing position for 1 minute.
- Change from Baseline in Sitting Pulse Rate. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The change between sitting pulse rate measured at week 12 or final visit from baseline. Sitting pulse rate is measured at least 3 times in 1- to 2-minute intervals after sitting ≥5 minutes, repeated until 2 consecutive stable measurements are obtained.
- Change from Baseline in Weight. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The change between weight recorded at week 12 or final visit from baseline.
- Change from Baseline in Resting 12-lead Electrocardiogram. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The change between electrocardiogram recorded at week 12 or final visit from baseline. Electrocardiogram interpreted using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.
- Number of Participants with a Markedly Abnormal Blood Urea Nitrogen Clinical Laboratory Value. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The number of participants with a markedly abnormal blood urea value nitrogen collected at week 12 or final visit from baseline.
- Number of Participants with a Markedly Abnormal Uric Acid Clinical Laboratory Value. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The number of participants with a markedly abnormal uric acid value collected at week 12 or final visit from baseline.
- Number of Participants with a Markedly Abnormal Creatinine Clinical Laboratory Value. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The number of participants with a markedly abnormal creatinine value collected at week 12 or final visit from baseline.
- Number of Participants with a Markedly Abnormal Creatine Kinase Clinical Laboratory Value. [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: Yes ]The number of participants with a markedly abnormal creatine kinase value collected at week 12 or final visit from baseline.
| Enrollment: | 926 |
| Study Start Date: | July 2007 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo-matching tablets, orally, once daily for up to 12 weeks.
|
| Experimental: Azilsartan 5 mg QD |
Drug: Azilsartan
Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.
Other Name: TAK-536
|
| Experimental: Azilsartan 10 mg QD |
Drug: Azilsartan
Azilsartan 10 mg, tablets, orally, once daily for up to 12 weeks.
Other Name: TAK-536
|
| Experimental: Azilsartan 20 mg QD |
Drug: Azilsartan
Azilsartan 20 mg, tablets, orally, once daily for up to 12 weeks.
Other Name: TAK-536
|
| Experimental: Azilsartan 40 mg QD |
Drug: Azilsartan
Azilsartan 40 mg, tablets, orally, once daily for up to 12 weeks.
Other Name: TAK-536
|
| Experimental: Azilsartan 80 mg QD |
Drug: Azilsartan
Azilsartan 80 mg, tablets, orally, once daily for up to 12 weeks.
Other Name: TAK-536
|
| Active Comparator: Candesartan Cilexetil 8 mg titrated to12 mg QD |
Drug: Candesartan cilexetil
Candesartan cilexetil 8 mg, tablets, orally, once daily for 4 weeks; titrated to 12 mg, tablets, orally, once daily for up to 8 weeks.
Other Names:
|
Detailed Description:
Hypertension is known to cause multiple organ damage by being combined with not only blood pressure but also other hemodynamics, endocrinological/metabolic abnormalities and genetic factors. This becomes a medically and medical-economically significant problem in Japan The significance of early treatment of hypertension and of long-term control of blood pressure has been increasing year by year.
Takeda Pharmaceutical Company Limited invented TAK-536 (azilsartan), an angiotensin II receptor blocker for decreasing blood pressure. This study investigating the efficacy and safety of azilsartan using candesartan cilexetil, a widely used antihypertensive drug, as a reference control.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Has mild to moderate uncomplicated essential hypertension.
- Has a sitting diastolic blood pressure between 95 and <110 mmHg and sitting systolic blood pressure between 150 and <180 mmHg at placebo run-in period (Week -2) or randomization visit.
Exclusion Criteria:
- Has a cardiovascular disease or symptoms
- Has been treated with more than 3 different antihypertensives within 27 days prior to placebo run-in period.
- Has a significant hepatic disorder, hyperkalemia, malignant tumor or significant renal impairment.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Sr. Manager, Clinical Planning, Takeda Pharmaceutical Company Limited (Japan) |
| ClinicalTrials.gov Identifier: | NCT01289132 History of Changes |
| Other Study ID Numbers: | TAK-536/CCT-001, U1111-1118-3346 |
| Study First Received: | February 1, 2011 |
| Last Updated: | February 1, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Takeda Global Research & Development Center, Inc.:
|
Drug Therapy |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Candesartan cilexetil Candesartan Angiotensin II Type 1 Receptor Blockers |
Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013