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A double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of add-on RANCAD on exercise tolerance and angina frequency in patients with stable angina pectoris.
Primary objective is to to determine the effects of add-on RANCAD on exercise treadmill test (ETT) duration at trough plasma level of RANCAD level after 12-weeks therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RANCAD 500mg | Experimental | RANCAD 1 tab (500 mg) + Placebo 1 tab, twice daily. |
|
| RANCAD 1000mg | Experimental | RANCAD 2 tabs (500 mg), twice daily |
|
| Placebo | Active Comparator | 2 tabs, twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RANCAD | Drug | Extended-Release RANCAD |
|
| Measure | Description | Time Frame |
|---|---|---|
| ETT performing at last treatment visit (Week 12). | To compare the change from baseline of ETT performing duration between add-on RANCAD and placebo at trough (12 hours after dosing) at Week 12. | Week 12 (not including screening & follow-up period) |
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Inclusion Criteria:
Exclusion Criteria:
Factors that might compromise ECG or ETT interpretation
Patients with family history of (or congenital) long QT syndrome
Patients with congenital heart disease
Patients with uncorrected valvular heart disease
Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study
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:
Use of any investigational product ≤ 4 weeks prior to screening
Patients with severe hepatic disease (e.g., liver cirrhosis)
Patients with impaired renal function (defined as serum Cr >1.5 mg/dl)
Patients with any condition or disease which is considered not suitable for this study by investigator
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| Name | Affiliation | Role |
|---|---|---|
| Juey-Jen Hwang, M.D., Ph.D., | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | New Taipei City | New Taipei city | 220 | Taiwan | ||
| Mackay Memorial Hospital |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Taipei |
| Taipei City |
| 104 |
| Taiwan |
| Shin Kong WuHoSu Memorial Hospital | Taipei | 111 | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Linkou Chang Gung Memorial Hospital | Taoyuan | 333 | Taiwan |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |