NCT01475578

Study of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)

A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel, Comparative, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of STA-1 Capsule in Patients With Vascular Dementia (Marrow-Sea Deficiency)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Sinphar Pharmaceutical Co., Ltd · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this phase II study of STA-1 capsule was to make preliminary evaluation on clinical efficacy and safety of STA-1 capsule in order that based on the dosage and study structure planned in this project, the dosage and study structure of phase III study can be confirmed.

Detailed description

This phase II clinical trial was planned to be in double-blind, double-dummy, active-controlled, parallel, comparative, multicenter design. Two hundred and 40 eligible subjects were planned to be recruited by 5 study centers. The treatment period planned in the protocol was 3 months with 5 study visits including Randomization visit (Day 0), three post-treatment visits (1 and 2 months after Randomization visit and Final visit) and 1 follow-up visit made at 6 month after Randomization visit. After subjects recruited by this study having read and singed the ICF, they were arranged to be collected information of demographics, medical history, allergy history, medication history, and concomitant medication. Laboratory and physical examination including vital signs were performed, and Hachinski Ischemia Score (HIS), Mini-Mental Status Examination (MMSE), and Classification of Marrow-Sea deficiency were evaluated to ensure subject's eligibility to enter this study. After the subjects were confirmed eligible, they were randomly assigned to either STA-1 or Ergoloid Mesylates group. Blessed-Roth Behavior Scale (BBS) and Activities of Daily Living (ADL) Scale were measured after subjects were randomized. These subjects were then dispensed study medications for 1-month use. The eligible subjects were requested to bring back unused study medication, if any, to study centers at 1, 2, and 3 months (Final visit) after the Randomization visit. At these visits, measurements of MMSE, BBS, ADL scales, and Classification of Marrow-Sea deficiency were collected. Information concomitant medications and AEs were also recorded. Physical and laboratory examinations were performed at Final visit. Each subject was dispensed with study medications for his/her subsequent treatment period at month-1 and -2 visits. Unused study medications were collected with drug accountability documented. Subjects were dismissed from the study at the Final visit. Subjects were measured MMSE, BBS, and ADL scales at 6 months after the Randomization visit if they were available for follow-up evaluations.

Conditions

• Vascular Dementia

Interventions

Type	Name	Description
DRUG	STA-1	STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally
DRUG	Ergoloid Mesylates tablet	Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-10-01
• Completion: 2002-10-01
• First posted: 2011-11-21
• Last updated: 2011-11-21

Locations

5 sites across 1 country: China