Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02480764
Other study ID # TAK-491_305
Secondary ID U1111-1159-5579
Status Completed
Phase Phase 3
First received
Last updated
Start date August 27, 2015
Est. completion date October 13, 2017

Study information

Verified date February 2019
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the antihypertensive effect of azilsartan medoxomil compared with valsartan in Chinese participants with essential hypertension.


Description:

The drug being tested in this study is called TAK-491 (azilsartan medoxomil). Azilsartan medoxomil is being tested to treat Chinese people who have essential hypertension. This study will look at change in blood pressure after 8 weeks of treatment in people who take azilsartan medoxomil compared to people who take valsartan.

The study enrolled 612 patients. Prior to the start of study treatment, participants who have not received antihypertensive treatment within 28 days participated in a 2-week -run in period. Upon completion of the run-in period, participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups—which remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

- azilsartan medoxomil 40 mg

- azilsartan medoxomil 80 mg

- Valsartan 160 mg

All participants were asked to take study medication at the same time each day throughout the study.

This multi-centre trial was conducted in China. The overall time to participate in this study is up to 14 weeks. Participants made 9 visits to the clinic and contacted by telephone 14 days after last dose of study drug for a follow-up assessment.


Recruitment information / eligibility

Status Completed
Enrollment 612
Est. completion date October 13, 2017
Est. primary completion date September 22, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Is treated with antihypertensive therapy and has a post-washout mean sitting clinic systolic blood pressure (SBP) =150 and =180 mm Hg on Day 1; or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting clinic SBP =150 and =180 mm Hg at the Screening Visit and on Day 1.

2. Is a man or woman aged 18 years or older.

3. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

4. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

5. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent through 30 days after last study drug dose.

6. Has clinical laboratory test results (clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant.

7. Is willing to discontinue current antihypertensive medications on Day -21 or on Day -28 if the participant is on amlodipine or chlorthalidone.

Exclusion Criteria:

1. Has a mean, sitting clinic diastolic blood pressure (DBP) greater than 110 mm Hg at Day 1 (after placebo run in).

2. Is non-compliant (less than 70% or greater than 130%) with study medication during placebo run-in period.

3. Has secondary hypertension of any etiology (eg, renovascular disease documented as the cause of hypertension, pheochromocytoma, Cushing's syndrome).

4. Has a history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack.

5. Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).

6. Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease and hypertrophic obstructive cardiomyopathy (HOCM).

7. Has severe renal dysfunction or disease (based on estimated glomerular filtration rate [GFR] <30 mL/min/1.73 m^2) at Screening.

8. Has known or suspected unilateral or bilateral renal artery stenosis.

9. Has a history of cancer that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not apply to those participants with basal cell or Stage 1 squamous cell carcinoma of the skin).

10. Has type 1 or poorly controlled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8.5%) at Screening.

11. Has hyperkalemia (defined as serum potassium above the normal reference range of the central laboratory) at Screening.

12. Has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level of greater than 2.5 times the upper limit of normal (ULN), active liver disease, or jaundice at Screening.

13. Has any other known serious disease or condition at Screening (or Randomization) that would compromise participant safety, might affect life expectancy, or make it difficult to successfully manage and follow the participant according to the protocol.

14. Has a history of hypersensitivity or allergies to TAK-491 (azilsartan medoxomil), any of its excipients or other angiotension II (AII) receptor blockers (ARBs).

15. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.

16. Is currently participating in another investigational study or is receiving or has received any investigational compound within 30 days prior to the first dose of study medication.

Note: This criterion does not apply to participants who participated in observational studies that lacked an intervention or invasive procedure.

17. Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

18. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within the past 2 years.

19. Is taking or expected to take an excluded medication.

20. Works a night (third) shift (defined as 11 PM [2300] to 7 AM [0700]). (Only for participants with ambulatory blood pressure monitoring [ABPM].)

21. Has an upper arm circumference <24 cm or >42 cm. (Only for participants with ABPM.)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Azilsartan medoxomil
Azilsartan medoxomil tablets
Valsartan
Valsartan 80 mg capsules
Azilsartan medoxomil Placebo
Azilsartan medoxomil placebo-matching tablets
Valsartan Placebo
Valsartan placebo-matching capsules

Locations

Country Name City State
China Beijing Anzhen Hospital Beijing Beijing
China Beijing Chao Yang Hospital Beijing Beijing
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing
China Beijing Tong Ren Hospital, Capital Medical University Beijing Beijing
China Hebei Cangzhou Central Hospital Cangzhou Hebei
China China-Japan Union Hospital of Jilin University Changchun Jilin
China Hunan Province People's Hospital Changsha Hunan
China The Third Xiangya Hospital of Central South University Changsha Hunan
China Fujian Medical University Union Hospital Fuzhou Fujian
China Fujian Provincial Hospital Fuzhou Fujian
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China Zhuzhou Central Hospital Fuzhou Hunan
China Guangdong General Hospital Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China Affiliated Hospital of Hainan Medical University. Haikou Hainan
China The First Affiliated Hospital of NanChang University Nanchang Jiangxi
China Cardiology/Zhong Da Hospital, Southeast University Nanjing Jiangsu
China Nanjing Medical University Affiliated 2nd Hospital Nanjing Jiangsu
China The Peoples Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi
China Shanghai Changzheng Hospital Shanghai Shanghai
China Shanghai East Hospital Shanghai Shanghai
China People's Hospital of Liaoning Province Shenyang Liaoning
China The 4th Hospital of Hebei Medical University Shijiazhuang Hebei
China Cardiology/The Second Hospital of Shanxi Medical University Taiyuan Shanxi
China TEDA International Cardiovascular Hospital Tianjin Tianjin
China Tianjin People's Hospital Tianjin Tianjin
China Tianjin Third Central Hospital Tianjin Tianjin
China First Affiliated Hospital of Xian Jiaotong University Xi'an Shanxi
China The Affiliated Hospital of Xuzhou Medical College Xuzhou Jiangsu
China Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP) The change in trough clinic sitting SBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting SBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. Baseline and Week 8
Secondary Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP) The change in trough clinic sitting DBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting DBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. Baseline and Week 8
Secondary Percentage of Participants Who Achieved a Clinic SBP Response at Week 8 Clinic SBP response was defined as clinic SBP <140 mm Hg and/or reduction of =20 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. Week 8
Secondary Percentage of Participants Who Achieved a Clinic DBP Response at Week 8 Clinic DBP response was defined as clinic DBP <90 mm Hg and/or reduction of =10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. Week 8
Secondary Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8 Clinic SBP response was defined as clinic SBP <140 mm Hg and/or reduction of =20 mm Hg from Baseline and clinic DBP response was defined as clinic DBP <90 mm Hg and/or reduction of =10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. Week 8
Secondary Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8 Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. Week 8
Secondary Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8 Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose. Week 8
See also
  Status Clinical Trial Phase
Recruiting NCT03708601 - Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)
Not yet recruiting NCT05503953 - Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS Phase 3
Recruiting NCT05526703 - Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy Phase 3
Completed NCT06395194 - Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension Phase 3
Not yet recruiting NCT06418074 - Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity N/A
Completed NCT02890173 - Study of CS-3150 in Patients With Essential Hypertension Phase 3
Completed NCT02944734 - Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension Phase 2
Withdrawn NCT02096939 - Microvascular Function in Primary Aldosteronism N/A
Recruiting NCT01956786 - Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine Phase 2/Phase 3
Completed NCT02553512 - Helius in Hypertension-I: The UK Hypertension Registry N/A
Completed NCT01198249 - Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension Phase 1
Completed NCT01001572 - Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension Phase 3
Recruiting NCT00380289 - Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension N/A
Completed NCT00139698 - Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension Phase 3
Completed NCT00288184 - Uric Acid in Essential Hypertension in Children Phase 2
Completed NCT01289886 - Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects Phase 1
Not yet recruiting NCT06041529 - Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension Phase 4
Completed NCT04470830 - A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
Completed NCT00758524 - A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension Phase 2
Recruiting NCT05109013 - Juvenile Essential Arterial Hypertension and Vascular Function