NCT01637675 (STS) is a Phase 2/Phase 3 clinical trial of 20 mg sildenafil citrate by mouth in Pulmonary Hypertension, sponsored by The First Affiliated Hospital of Guangzhou Medical University.

Who is sponsoring NCT01637675?

NCT01637675 is sponsored by The First Affiliated Hospital of Guangzhou Medical University.

What drugs are being tested in NCT01637675?

Interventions in NCT01637675: 20 mg sildenafil citrate by mouth, sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth.

What condition does NCT01637675 study?

NCT01637675 studies Pulmonary Hypertension, Pulmonary Arterial Hypertension, Cardiovascular Diseases, Lung Diseases, Tanshinone IIA Sulfonate.

Is NCT01637675 still recruiting?

NCT01637675 is currently status unknown. Last updated 28 March 2014.

Last reviewed 2014-03-28 · How we verify

NCT01637675: STS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension

Status unknown Phase 2/Phase 3 Last updated 28 March 2014

What this trial tests

Phase 2/Phase 3 trial testing 20 mg sildenafil citrate by mouth in Pulmonary Hypertension in 90 participants. Status unknown.

Timeline

1 May 2013

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	The First Affiliated Hospital of Guangzhou Medical University
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	1 May 2013
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	1 location across China

Drugs / interventions tested

20 mg sildenafil citrate by mouth — full drug profile →
sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth — full drug profile →

Conditions studied

Pulmonary Hypertension — all drugs for Pulmonary Hypertension →
Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →
Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
Lung Diseases — all drugs for Lung Diseases →

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Who can join

Adults 15 to 70, any sex, with Pulmonary Hypertension or Pulmonary Arterial Hypertension. 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.

mPAP by right heart catheterization
Time frame: At the end of 0- and 8-week trial
To assess if sodium Tanshinone IIA sulfonate decreases mean pulmonary arterial pressure.

Sponsor's own description

Sodium tanshinone IIA sulfonate (STS) is a water-soluble derivative of tanshinone IIA isolated as the main pharmacologically active natural compound from a traditional Chinese herbal medicine,the dried root of Salvia miltiorrhiza Bunge known as Danshen. Danshen has been known for the function of improving body functions such as activating blood circulation and removing blood stasis according to the theory of traditional Chinese medicine. Danshen and its various formula products including STS have been long-time widely used in oriental countries, especially China to treat various inflammatory and cardiovascular diseases for its pharmacological actions, including vasodilatation, anticoagulation, anti-inflammation, and free radical scavenging,with negligible adverse effects observed. The investigator's objective is to evaluate whether STS exhibits beneficial effects on pulmonary hypertension. This is a randomized, controlled, multicentre clinical trial study. 90 patients with pulmonary hypertension will be enrolled in this study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Tanshinone I activates the Nrf2-dependent antioxidant response and protects against As(III)-induced lung inflammation in vitro and in vivo.
Tao S, Zheng Y, Lau A, Jaramillo MC, et al · · 2013 · cited 80× · PMID 23394605 · DOI 10.1089/ars.2012.5117
Ferroptosis-modulating small molecules for targeting drug-resistant cancer: Challenges and opportunities in manipulating redox signaling.
Koeberle SC, Kipp AP, Stuppner H, Koeberle A. · · 2023 · cited 74× · PMID 36658724 · DOI 10.1002/med.21933
Traditional Herbal Medicine Discovery for the Treatment and Prevention of Pulmonary Arterial Hypertension.
Xue Z, Li Y, Zhou M, Liu Z, et al · · 2021 · cited 24× · PMID 34899290 · DOI 10.3389/fphar.2021.720873
The Skeletal Effects of Tanshinones: A Review.
Ekeuku SO, Pang KL, Chin KY. · · 2021 · cited 14× · PMID 33923673 · DOI 10.3390/molecules26082319
Phytochemical-mediated efferocytosis and autophagy in inflammation control.
Vafadar A, Tajbakhsh A, Hosseinpour-Soleimani F, Savardshtaki A, et al · · 2024 · cited 11× · PMID 39695119 · DOI 10.1038/s41420-024-02254-2
Identification of tanshinone I as cap-dependent endonuclease inhibitor with broad-spectrum antiviral effect.
He X, Yang F, Wu Y, Lu J, et al · · 2023 · cited 7× · PMID 37732786 · DOI 10.1128/jvi.00796-23
Aurora kinases signaling in cancer: from molecular perception to targeted therapies.
Vats P, Saini C, Baweja B, Srivastava SK, et al · · 2025 · cited 6× · PMID 40533769 · DOI 10.1186/s12943-025-02353-3
Traditional Chinese medicine monomers: Targeting pulmonary artery smooth muscle cells proliferation to treat pulmonary hypertension.
Yang X, Yang Y, Liu K, Zhang C. · · 2023 · cited 6× · PMID 37128338 · DOI 10.1016/j.heliyon.2023.e14916

Verify or expand the search:

Other recruiting trials for Pulmonary Hypertension

Currently open trials in the same condition.

NCT07179380 — Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension · Phase 3 · recruiting
NCT07073820 — A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have P · Phase 2 · recruiting
NCT06351345 — 129 Xenon Imaging in Patients Treated With Sotatercept · Phase 2 · recruiting
NCT07187206 — Safety and Efficacy of FETO in CDH Phase III · Phase 3 · recruiting
NCT07206173 — Londrina Activities of Daily Living Protocol in Pulmonary Hypertension · recruiting

Other The First Affiliated Hospital of Guangzhou Medical University trials

Trials by the same sponsor.

NCT07413952 — Limertinib Plus Radiotherapy for EGFR-Mutant NSCLC With Brain Metastases · Phase 2 · not yet recruiting
NCT07395375 — Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection · NA · not yet recruiting
NCT07395362 — Hybrid Robot-Assisted Percutaneous Ablation and Non-Intubated VATS for Multiple Pulmonary Nodules · NA · not yet recruiting
NCT07395349 — Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection · NA · not yet recruiting
NCT07377916 — Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01637675 (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 The First Affiliated Hospital of Guangzhou Medical University
Last refreshed: 28 March 2014

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/NCT01637675.

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