New Angiotensin II Receptor Blocker Azilsartan Study for Stronger Blood Pressure Lowering (NARA)
This study is currently recruiting participants.
Verified June 2012 by Nara Medical University
Sponsor:
Nara Medical University
Information provided by (Responsible Party):
Yoshihiko Saito, Nara Medical University
ClinicalTrials.gov Identifier:
NCT01609959
First received: May 30, 2012
Last updated: June 2, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Azilsartan Drug: Valsartan |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of the New Angiotensin II Receptor Blocker Azilsartan Versus Valsartan on Blood Pressure in Japanese Patients With Hypertension |
Resource links provided by NLM:
Further study details as provided by Nara Medical University:
Primary Outcome Measures:
- Change in Office Blood Pressure [ Time Frame: Baseline and every 2 weeks (up to 12 weeks) ] [ Designated as safety issue: No ]Change in blood pressure measured at a clinic
Secondary Outcome Measures:
- Change in Home Blood Pressure [ Time Frame: Baseline and every 2 weeks (up to 12 weeks) ] [ Designated as safety issue: No ]
Change in blood pressure measured at home
Blood pressure is measured twice daily in the morning fasting before taking any drugs.
- Change in Renal Function [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Changes in levels of serum creatinine and proteinuria
- Change in Fasting Triglyceride [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
- Change in Glycemic Control [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Changes in levels of fasting blood glucose, hemogrobin A1C and fasting insulin (if needed)
- Change in Plasma Aldosterone Concentration [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Only in patients with secondary hypertension
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Azilsartan group |
Drug: Azilsartan
Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks
|
| Active Comparator: Valsartan group |
Drug: Valsartan
Valsartan 160 mg per day
|
Detailed 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609959
Contacts
| Contact: Yoshihiko Saito, MD, PhD | +81-744-22-3051 ext 3411 | yssaito@naramed-u.ac.jp |
| Contact: Sadanori Okada, MD, PhD | +81-744-22-3051 ext 3411 | saokada@naramed-u.ac.jp |
Locations
| Japan | |
| First Department of Nara Medical University | Recruiting |
| Kashihara, Nara, Japan, 634-8522 | |
| Contact: Yoshihiko Saito, MD, PhD +81-744-22-3051 ext 3411 yssaito@naramed-u.ac.jp | |
| Contact: Sadanori Okada, MD, PhD +81-744-22-3051 ext 3411 saokada@naramed-u.ac.jp | |
| Principal Investigator: Yoshihiko Saito, MD, PhD | |
Sponsors and Collaborators
Nara Medical University
Investigators
| Principal Investigator: | Yoshihiko Saito, MD, PhD | First Department of Internal Medicine, Nara Medical University |
More Information
No publications provided
| Responsible Party: | Yoshihiko Saito, Professor, Nara Medical University |
| ClinicalTrials.gov Identifier: | NCT01609959 History of Changes |
| Other Study ID Numbers: | 12-Ken-001 |
| Study First Received: | May 30, 2012 |
| Last Updated: | June 2, 2012 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Nara Medical University:
|
Hypertension Angiotensin II Receptor Blocker Azilsartan Valsartan |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Angiotensin II Valsartan Angiotensin Receptor Antagonists Vasoconstrictor Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 16, 2013