Trials / Withdrawn
WithdrawnNCT01972477
DLBS1449 in Diabetic Patients With Low HDL
The Effect of DLBS1449 in Diabetic Patients With Low HDL-Cholesterol - Double Blind Comparative Study With Placebo
- Status
- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Dexa Medica Group · Industry
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a parallel, 3-arm, randomized, prospective, placebo-controlled, and double-blind clinical study for eight weeks of therapy to investigate the clinical efficacy of DLBS1449 in elevating high density lipoprotein (HDL) cholesterol in diabetic patients. The hypothesis of interest for the study is: the administration of DLBS1449 will elevate HDL-cholesterol level from baseline to the end of study significantly higher than the elevation resulted by placebo. In addition, the administration of DLBS1449 at the dose of 150 mg daily will provide a significantly better response than that of the lower dose (DLBS1449 75 mg daily).
Detailed description
There will be three groups of treatment by dosage regimen in this study. Eligible subjects will be randomized to receive any of the following regimens: 1) DLBS1449 at a dose of 1 x 75 mg daily, or 2) DLBS1449 at a dose of 1 x 150 mg (two capsules of DLBS1449 75 mg) daily; or 3) placebo, once daily. Study medication should be administered once daily, in the evening with meal, for eight weeks. Clinical and laboratory examinations to evaluate investigational drug's efficacy and safety will be performed at baseline and at interval of four weeks over 8-week course of therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DLBS1449 | Study treatment will be DLBS1449 softcapsules at a dose of 1x75 mg daily or DLBS1449 at a dose of 1x150 mg daily. DLBS1449 will be given every day for 8 weeks. |
| OTHER | Placebo | Placebo will be given every day for 8 weeks. |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2017-10-01
- Completion
- 2018-01-01
- First posted
- 2013-10-30
- Last updated
- 2016-08-04
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT01972477. Inclusion in this directory is not an endorsement.