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Pulmonary HypertensionPhase 2/3STSNCT01637675

Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension

A Phase 2/3 study testing 20 mg sildenafil citrate by mouth and sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth in people with Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 70 years
What is being tested?
20 mg sildenafil citrate by mouth and sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
May 2013to Dec 2014
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Meet the condition of mean pulmonary arterial pressure (mPAP) ≥25 mmHg at seal level at rest and pulmonary capillary wedge pressure(PCWP)≤15mmHg;
  • Category 1 or 4 of PH in stable stage according to 2008 Dana Point Conference,including the idiopathic, hereditary, drugs and toxins induced, associated with connective tissue disease or congenital heart disease, and chronic thromboembolic pulmonary arterial hypertension(PAH) ;
  • Male or female between 15 to 70 years old;
  • WHO pulmonary hypertension functional class II or III;
  • The baseline 6-minute walk distance between 150-550 m;
  • Patients' condition should be stable for more than one month after basic treatment; For those patients with congenital heart disease, surgery should have been performed six months or more before they are enrolled in the study;
  • Patients receiving sildenafil treatment only previously, or those without target drugs treatment during the past 3 months;
  • Patients or their guardians should agree with this clinical trail and medical informed consent of the trial should be signed.

Who cannot join

  • Unavailable or limited legal capacity;
  • Pregnant or lactational women;
  • Important organs with severe diseases;
  • Mental or physical disability;
  • With suspected or indeed alcohol, drug abuse history;
  • With allergic constitution, with two or more drugs or foods allergy history or those who are allergic to any components of the experimental drugs;
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  • With both aspartate aminotransferase (AST) and glutamic-pyruvic transaminase (ALT) more than three times of the upper limit of normal in liver function test and Ccr≤50ml/min in kidney function test;
  • Those with systemic blood pressure<90/50 mmHg, or those uncontrolled dangerous hypertension(BP>170/110 mmHg);
  • Patients at active stages of infectious or other diseases such as hepatitis A, hepatitis B, AIDS, tuberculosis, and some connective tissue diseases;
  • Patients with severe infection, especially pulmonary infection;
  • Patients with shock or astable hemodynamics with other causes;
  • Patients with hepatic cirrhosis, and hepatic cirrhosis induced portal hypertension;
  • Patients with severe hemorrhage, and hemorrhagic tendency;
  • Patients who need to take or be taking drugs possible or indeed affecting this trial;
  • Patients cannot accomplish required items (especially 6MWD) because of acute/chronic organic disease (excluding dyspnea) or other illnesses such as lower extremity diseases;
  • Patients with any other conditions considered cannot be recruited.

Trial locations and contacts

1 site in 1 country.

Jian Wang, MD contact

+8615013388183

jwang31@jhmi.edu

China1 site, 1 recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

    Jian Wang, MD, +8615013388183, jwang31@jhmi.edu

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension

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.

Being tested
20 mg sildenafil citrate by mouth, sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth
Keywords
sodium tanshinone IIA sulfonate, pulmonary hypertension
Medical subject headings
Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Cardiovascular Diseases, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 20 mg sildenafil citrate by mouthDrug

    Also called Viagra

    20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks

  • sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouthDrug

    Also called Sodium tanshinone IIA sulfonate injection, Viagra

    sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection will also be permitted if necessary) 250ml iv drip once a day for 8 weeks,as well as 20mg sildenafil citrate tablets by mouth three times a day for the same duration of treatment

Study groups in NCT01637675
Study groupRoleWhat they receive
20 mg sildenafil citrate tablets by mouthActive comparator20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
Receives: Drug: 20 mg sildenafil citrate by mouth
sodium tanshinone IIA sulfonate, sildenafil citrate tabletsExperimentalsodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection also permitted if necessary) 250ml ivdrip once a day for 8 weeks,20mg sildenafil citrate tablets by mouth three times a day for the same duration
Receives: Drug: sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mPAP by right heart catheterization

    To assess if sodium Tanshinone IIA sulfonate decreases mean pulmonary arterial pressure.

    Measured: At the end of 0- and 8-week trial

Secondary outcomes (5)

  1. WHO functional class of pulmonary hypertension(PH)

    Measured: At the end of 0-,2-, 4-,6- and 8-week of trial

  2. Borg dyspnea score

    Measured: At the end of 0-, 2-,4-,6- and 8-week trial

  3. Minnesota living with heart failure questionnaire

    Measured: At the end of 0-,2-, 4-,6- and 8-week trial

  4. 6-minute walk distance (6MWD)

    To assess if sodium Tanshinone IIA sulfonate improves the exercise capacity of patients with pulmonary hypertension.

    Measured: At the end of 0-, 2-, 4-, 6- and 8-week trial

  5. Pulmonary vascular resistance(PVR) measured by right heart catheterization

    PVR is used to evaluate whether STS decreases mPAP or increases pulmonary circulatory blood flow.

    Measured: At the end of 0- and 8-week trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2012 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01637675
Sponsor's protocol ID
STS-PH01
Acronym
STS
Status last verified
Mar 2014
First submitted
1 Jul 2012
Last updated
31 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • He X, Yang F, Wu Y, Lu J, Gao X, Zhu X, Yang J, Liu S, Xiao G, Pan X. Identification of tanshinone I as cap-dependent endonuclease inhibitor with broad-spectrum antiviral effect. J Virol. 2023 Oct 31;97(10):e0079623. doi: 10.1128/jvi.00796-23. Epub 2023 Sep 21.

    PubMed 37732786

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 20 mg sildenafil citrate by mouth and sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth in people with Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jian Wang, MD (+8615013388183, jwang31@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mPAP by right heart catheterization (time frame: At the end of 0- and 8-week trial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01637675, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.

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