Clinical trial NCT01289132: Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Essential Hypertension
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 926
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12).
timeFrame: Baseline and Week 12.
Secondary outcomes:
measure: Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 2).
timeFrame: Baseline and Week 2.
measure: Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 4).
timeFrame: Baseline and Week 4.
measure: Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 6).
timeFrame: Baseline and Week 6.
measure: Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 8).
timeFrame: Baseline and Week 8.
measure: Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 10).
timeFrame: Baseline and Week 10.
measure: Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 2).
timeFrame: Baseline and Week 2.
measure: Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 4).
timeFrame: Baseline and Week 4.
measure: Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 6).
timeFrame: Baseline and Week 6.
measure: Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 8).
timeFrame: Baseline and Week 8.
measure: Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 10).
timeFrame: Baseline and Week 10.
measure: Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 12).
timeFrame: Baseline and Week 12.
measure: 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.
timeFrame: Baseline and Week 12.
measure: Number of Participants with a Sitting Trough Systolic Blood Pressure of <130 mmHg and a Sitting Trough Diastolic Blood Pressure of <85 mmHg.
timeFrame: Baseline and Week 12.
measure: Incidence of Adverse Events.
timeFrame: On occurrence (up to Week 12).
measure: Change from Baseline in Supine Systolic Blood Pressure.
timeFrame: Baseline and Week 12.
measure: Change from Baseline in Supine Diastolic Blood Pressure.
timeFrame: Baseline and Week 12.
measure: Change from Baseline in Standing Systolic Blood Pressure.
timeFrame: Baseline and Week 12.
measure: Change from Baseline in Standing Diastolic Blood Pressure.
timeFrame: Baseline and Week 12.
measure: Change from Baseline in Sitting Pulse Rate.
timeFrame: Baseline and Week 12.
measure: Change from Baseline in Weight.
timeFrame: Baseline and Week 12.
measure: Change from Baseline in Resting 12-lead Electrocardiogram.
timeFrame: Baseline and Week 12.
measure: Number of Participants with a Markedly Abnormal Blood Urea Nitrogen Clinical Laboratory Value.
timeFrame: Baseline and Week 12.
measure: Number of Participants with a Markedly Abnormal Uric Acid Clinical Laboratory Value.
timeFrame: Baseline and Week 12.
measure: Number of Participants with a Markedly Abnormal Creatinine Clinical Laboratory Value.
timeFrame: Baseline and Week 12.
measure: Number of Participants with a Markedly Abnormal Creatine Kinase Clinical Laboratory Value.
timeFrame: Baseline and Week 12.
Other outcomes:
Locations:
Study officials:
affiliation: Osaka University Graduate School of Medicine
name: Professor Geriatric Medicine and Nephrology
role: STUDY_DIRECTOR
References: