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NCT ID: NCT01705977 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab Assessment of Safety in SLE

BASE
Start date: November 27, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

NCT ID: NCT01702571 Completed - Breast Cancer Clinical Trials

A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

Start date: November 27, 2012
Phase: Phase 3
Study type: Interventional

This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

NCT ID: NCT01694537 Completed - Healthy Clinical Trials

The Effects of DLBS1033 on Haemostasis Parameters in Healthy Volunteers

Start date: July 2012
Phase: Phase 2
Study type: Interventional

DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm. This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight Proteins (LLP). This enzym can be transported to the bloodstream via intestinal epitel. Structure of DLBS1033 looks like lumbrokinase. Lumbrokinase is enzym that consist of 6 isoenzyme serine protease. As a drug that consists of serin protease enzym, suspected that the mechanism of action of DLBS1033 similar with lumbrokinase, especially as plasminogen activator in fibrinolytic system. In vitro study by Trisina et al showed that DLBS1033 has fibrinogenolytic activities on fibrinogen α, beta, and gamma chain, decreasing platelet aggregation and clotting time was prolonged. Until now, the mechanism of action and effects of DLBS1033 on human fibrinolytic and coagulation system still unknown. Therefore, the aim of this clinical trial is to evaluate the effects of DLBS1033 on human fibrinolytic and coagulation system on healthy subjects.

NCT ID: NCT01682577 Completed - Healthy Clinical Trials

Bioequivalence Study of Two Formulations of Perindopril 4 mg Tablet Under Fasting Condition

Start date: September 2008
Phase: N/A
Study type: Interventional

The objective of this study was to find out whether the bioavailability of PT Dexa Medica's formulation of 4 mg perindopril tert-butylamine tablets was equivalent to that of the innovator's product (Prexum® 4 mg, Servier).

NCT ID: NCT01681355 Completed - Healthy Infants Clinical Trials

Gastrointestinal Tolerance Study of a New Infant Formula

BOOGIE
Start date: September 2012
Phase: N/A
Study type: Interventional

This study is initiated to investigate the gastrointestinal tolerance of a new infant formula in healthy, term, Asian infants.

NCT ID: NCT01681056 Completed - Clinical trials for Quality of Life for Geriatric Patients.

Efficacy Study of Autosuggestion for Quality of Life of Geriatric Patients

ESAQoGe
Start date: August 2010
Phase: N/A
Study type: Interventional

The objective is to analyze the efficacy of autosuggestion for geriatric patients's quality of life and its impact to psycho-neuro-endocrine-immune pathways. The primary outcome is quality of life. The hypothesis of this study is that autosuggestion will increase geriatric patient's quality of life based on its impact to psycho-neuro-endocrine-immune pathways.

NCT ID: NCT01677598 Completed - Plaque Psoriasis Clinical Trials

A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries

MARCOPOLO
Start date: December 2011
Phase: Phase 4
Study type: Observational

The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.

NCT ID: NCT01677260 Completed - Clinical trials for Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose

Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet

Start date: October 2009
Phase: N/A
Study type: Interventional

This was a single centre, single-blind, randomized, balanced, combined single dose study under fasting condition and multiple doses study under fed condition with normal diabetic-meal, two-period, two-sequence cross-over study to to compare the bioavailability of metformin hydrochloride 500 mg extended release caplet (test drug) and metformin hydrochloride 500 mg prolonged release tablet (reference formulation).

NCT ID: NCT01677247 Completed - Clinical trials for Glimepiride BE Study in Healthy Volunteers Under Fasting Condition

Bioequivalence Study of 4 mg Glimepiride Tablet

Start date: February 2011
Phase: N/A
Study type: Interventional

This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).

NCT ID: NCT01670045 Completed - Clinical trials for Rheumatoid Arthritis

A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

Start date: March 2012
Phase: N/A
Study type: Observational

This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.