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Completed

NCT Number: NCT01289132

Efficacy and Safety of Azilsartan in Participants With Mild to Moderate Uncomplicated Essential Hypertension

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo-matching tablets, orally, once daily for up to 12 weeks.

Azilsartan

Drug

Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.

Other names: TAK-536

Candesartan cilexetil

Drug

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: Blopress®, TCV-116

Primary outcomes

  1. Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 12).

    Time frame: Baseline and Week 12.

    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 outcomes

  1. Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 2).

    Time frame: Baseline and Week 2.

    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.

  2. Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 4).

    Time frame: Baseline and Week 4.

    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.

  3. Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 6).

    Time frame: Baseline and Week 6.

    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.

  4. Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 8).

    Time frame: Baseline and Week 8.

    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.

  5. Change from Baseline in Sitting Trough Diastolic Blood Pressure (Week 10).

    Time frame: Baseline and Week 10.

    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.

  6. Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 2).

    Time frame: Baseline and Week 2.

    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.

  7. Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 4).

    Time frame: Baseline and Week 4.

    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.

  8. Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 6).

    Time frame: Baseline and Week 6.

    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.

  9. Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 8).

    Time frame: Baseline and Week 8.

    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.

  10. Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 10).

    Time frame: Baseline and Week 10.

    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.

  11. Change from Baseline in Sitting Trough Systolic Blood Pressure (Week 12).

    Time frame: Baseline and Week 12.

    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.

  12. 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.

    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.

  13. 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.

    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.

  14. Incidence of Adverse Events.

    Time frame: On occurrence (up to Week 12).

    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.

  15. Change from Baseline in Supine Systolic Blood Pressure.

    Time frame: Baseline and Week 12.

    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.

  16. Change from Baseline in Supine Diastolic Blood Pressure.

    Time frame: Baseline and Week 12.

    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.

  17. Change from Baseline in Standing Systolic Blood Pressure.

    Time frame: Baseline and Week 12.

    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.

  18. Change from Baseline in Standing Diastolic Blood Pressure.

    Time frame: Baseline and Week 12.

    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.

  19. Change from Baseline in Sitting Pulse Rate.

    Time frame: Baseline and Week 12.

    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.

  20. Change from Baseline in Weight.

    Time frame: Baseline and Week 12.

    The change between weight recorded at week 12 or final visit from baseline.

  21. Change from Baseline in Resting 12-lead Electrocardiogram.

    Time frame: Baseline and Week 12.

    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.

  22. Number of Participants with a Markedly Abnormal Blood Urea Nitrogen Clinical Laboratory Value.

    Time frame: Baseline and Week 12.

    The number of participants with a markedly abnormal blood urea value nitrogen collected at week 12 or final visit from baseline.

  23. Number of Participants with a Markedly Abnormal Uric Acid Clinical Laboratory Value.

    Time frame: Baseline and Week 12.

    The number of participants with a markedly abnormal uric acid value collected at week 12 or final visit from baseline.

  24. Number of Participants with a Markedly Abnormal Creatinine Clinical Laboratory Value.

    Time frame: Baseline and Week 12.

    The number of participants with a markedly abnormal creatinine value collected at week 12 or final visit from baseline.

  25. Number of Participants with a Markedly Abnormal Creatine Kinase Clinical Laboratory Value.

    Time frame: Baseline and Week 12.

    The number of participants with a markedly abnormal creatine kinase value collected at week 12 or final visit from baseline.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 3, 2011
Registry last updated
Feb 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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