An interventional study of Ranolazine and Placebos in Angina, sponsored by TSH Biopharm Corporation Limited. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by TSH Biopharm Corporation Limited · Not applicable, Interventional, and Treatment
This is a double-blind, randomized, placebo-controlled, and parallel study. The study is comprised of three main phases: a single-blind placebo run-in qualifying phase lasting about 14 days, a double-blind treatment phase of 12 weeks, and a 2-week follow-up phase. Approximately 18 patients will be enrolled and randomly assigned to receive placebo or 1,000 mg of extended-release Ranolazine twice-daily for 12 weeks to reach 14 evaluable patients at the end of the study.
This is a double-blind, randomized, placebo-controlled, and parallel study. The study is comprised of three main phases: a single-blind placebo run-in qualifying phase lasting about 14 days, a double-blind treatment phase of 12 weeks, and a 2-week follow-up phase. Approximately 18 patients will be enrolled and randomly assigned to receive placebo or 1,000 mg of extended-release Ranolazine twice-daily for 12 weeks to reach 14 evaluable patients at the end of the study.
Patients with chronic angina pectoris will be screened for eligibility after providing informed consent. Patients present with the symptoms of stable angina after withdrawn from other antianginal agents and given the required background therapy for at least 5 days will be qualified for entering this study and performing 1st ETT qualifying test.
Patients with diagnosis of coronary artery disease (CAD) via at least one of the following criteria:
History of previous myocardial infarction (MI)*;
*Previous MI history of patients has to be occurred and diagnosed at least 2 months prior entering this study.
Exclusion Criteria:
Factors that might compromise ECG or ETT interpretation.
Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential* who is not using medically recognized method of contraception.
*Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal.
Patients are under any one of the following conditions:
Ranolazine 1000 mg
Drug: Ranolazine
Placebos
Drug: Placebos
Oral, b.i.d
Also known as: RNTA
Oral, b.i.d
Also known as: Placebo
ETT performing duration
To compare the change from baseline of ETT performing duration between add-on Ranolazine and placebo
Time frame: at trough (12 hours after dosing) at Week 12
Plan to share: No
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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TSH Biopharm Corporation Limited