New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering

Hypertension Clinical Trial

— NARA  

Official title:

Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609959
• Other study ID #: 12-Ken-001
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2012
• Last updated: October 28, 2013
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Nara Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in Japanese patients with hypertension who have already taken normal-dose angiotensin II receptor blockers.

Description:

Hypertension plays a major role in the development of cardiovascular disease. Several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor.

A new angiotensin II receptor blocker (ARB), azilsartan, is the first drug which is superior to other ARBs in blood pressure lowering in phase III clinical trials in Japan. We try to evaluate effect of azilsartan on blood pressure lowering in Japanese patients with hypertension who have already taken normal-dose ARBs, and to compare it with that of valsartan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Hypertensive patients treated with normal-dose angiotensin II receptor blockers (ARBs) in Japan

• Normal-dose ARBs in Japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day.

Exclusion Criteria:

• Hypersensitivity for azilsartan and valsartan

• Pregnant female

• History of azilsartan use within 3 months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Azilsartan
Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks
• Valsartan
Valsartan 160 mg per day

Locations

Country	Name	City	State
Japan	First Department of Nara Medical University	Kashihara	Nara

Sponsors (1)

Lead Sponsor	Collaborator
Nara Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Office Blood Pressure	Change in blood pressure measured at a clinic	Baseline and every 2 weeks (up to 12 weeks)	No
Secondary	Change in Home Blood Pressure	Change in blood pressure measured at home; Blood pressure is measured twice daily in the morning fasting before taking any drugs.	Baseline and every 2 weeks (up to 12 weeks)	No
Secondary	Change in Renal Function	Changes in levels of serum creatinine and proteinuria	Baseline and 12 weeks	No
Secondary	Change in Fasting Triglyceride		Baseline and 12 weeks	No
Secondary	Change in Glycemic Control	Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)	Baseline and 12 weeks	No
Secondary	Change in Plasma Aldosterone Concentration	Only in patients with secondary hypertension	Baseline and 12 weeks	No