# The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

> **NCT01566695** · PHASE3 · COMPLETED · sponsor: **Celgene** · enrollment: 216 (actual)

## Conditions studied

- Myelodysplastic Syndrome

## Interventions

- **DRUG:** Oral Azacitidine
- **DRUG:** Placebo
- **OTHER:** Best Supportiv Care (BSC)

## Key facts

- **NCT ID:** NCT01566695
- **Lead sponsor:** Celgene
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-04-26
- **Primary completion:** 2019-01-25
- **Final completion:** 2023-12-21
- **Target enrollment:** 216 (ACTUAL)
- **Last updated:** 2025-01-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01566695

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01566695, "The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT01566695. Licensed CC0.

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