Combination Therapy of Olmesartan and Azelnidipine or Valsartan and Amlodipine in Hypertensinve Patients Study

Phase 4

• Conditions: Hypertension

• Registration Number: JPRN-UMIN000004288
• Lead Sponsor: Hiroshima University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-28
• Study Completion: 2010-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Subjects with cardiogenic shock or a SBP of <80 mmHg. (2) Subjects with serious arrhythmia (such as persistent ventricular tachycardia and ventricular fibrillation), bradycardia (<50 beat/min), or second-degree or greater atrioventricular block. (3) Subjects who have developed acute cardiac infarction within 3 months prior to informed consent. (4) Subjects with unstable angina, coronary spastic angina, or angina at rest. (5) Subjects who have undergone CABG or PCI within 3 months prior to informed consent or are going to undergo CABG or PCI during the study. (6) Subjects who have developed cerebrovascular disorders (such as cerebral hemorrhage and subarachnoid hemorrhage) within 6 months prior to informed consent. (7) Subjects with bronchial asthma or other chronic respiratory disease and cor pulmonale. (8) Subjects with a history of disease with a serious prognosis such as advanced cancer within 5 years prior to informed consent. (9) Subjects with arteriosclerosis obliterans (stage II or greater in Leriche Fontaine's classification). (10) Subjects with poorly controlled diabetes mellitus (subjects with an HbAlc of >=8.0% even in antidiabetic treatment). (11) Subjects with the following serious complications: renal disorder (e.g., persistent creatinine of >=3.0 mg/dL), hepatic disorder (e.g., persistent AST or ALT of >=100 units), and anemia (e.g., persistent Hb of <=8.0 mg/dL). (12) Subjects with thyroid dysfunction difficult to control with treatment. (13) Pregnant and lactating women, women of childbearing potential, or women who want to get pregnant during the study. (14) Subjects with a history of hypersensitivity to olmesartan, valsartan, azelnidipine, and/or amlodipine. (15) Subjects for whom the administration of olmesartan, valsartan, azelnidipine, and/or amlodipine is contraindicated. (16) Subjects who are unable to give informed consent in writing. (17) Subjects judged by the investigator to be ineligible for the study due to other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified