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NCT01151202
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup" in Acute Upper Respiratory Tract Infection and Chronic Inflammatory Bronchitis Patients: Double Blinded, Randomized, Active Drug Comparative, Parallel Designed, Multi-centered, Phase III Study
Phase 3 trial testing AG NPP709syrup in Acute Upper Respiratory Tract Infections in 236 participants. Completed in 1 June 2010.
1 May 2010
Quick facts
| Lead sponsor | Ahn-Gook Pharmaceuticals Co.,Ltd |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 236 |
| Start date | 1 February 2010 |
| Primary completion | 1 May 2010 |
| Estimated completion | 1 June 2010 |
| Sites | 6 locations across South Korea |
Drugs / interventions tested
- AG NPP709syrup — full drug profile →
Conditions studied
- Acute Upper Respiratory Tract Infections — all drugs for Acute Upper Respiratory Tract Infections →
- Bronchitis — all drugs for Bronchitis →
Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd — full company profile →
Who can join
Adults 24 Months to 75, any sex, with Acute Upper Respiratory Tract Infections or Bronchitis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
improvement by global assessment
Time frame: 5 days
At closing visit, researcher assess clinical efficacy using the following five criteria (4: cure, 3: significant improvement, 2: improvement, 1: some improvement, 0: non-improvement or worsening of symptoms). Upper the Grade 3 outcomes are defined as "clinical success".
Sponsor's own description
The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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The clinical efficacy of AG NPP709 (Synatura<sup>®</sup>) in patients with chronic bronchitis type stable chronic obstructive pulmonary disease.
Lee EG, Rhee CK. · · 2020 · cited 11× · PMID 32642149 · DOI 10.21037/jtd.2020.03.61 -
Randomized, Double-Blind, Multicenter, Phase 3 Study of AG NPP709 Compared With Ivy Leaf Extract in Patients With Acute or Chronic Respiratory Symptoms.
Cho YJ, Yoon HJ, Lim DH, Yoo KH, et al · · 2026 · PMID 41807028 · DOI 10.3346/jkms.2026.41.e97
Verify or expand the search:
- PubMed search for NCT01151202
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Ahn-Gook Pharmaceuticals Co.,Ltd trials
Trials by the same sponsor.
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- NCT05503953 — Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Contr · Phase 3 · unknown
- NCT04686643 — Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension · Phase 3 · unknown
- NCT05206578 — Study to Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia · Phase 3 · unknown
- NCT04554303 — Comparing Safety and Efficacy of Amlodipine Verses S Amlodipine in Patients With Essential Hypertension · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01151202 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ahn-Gook Pharmaceuticals Co.,Ltd
- Last refreshed: 3 October 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01151202.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing