Clinical trial of Angipars in patients with pulmonary hypertension.

Phase II clinical trial of oral form Angipars on quality of life and pulmonary artery pressure in patients with primary pulmonary hypertension without control group.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000359033

Enrollment

Registered

2010-05-06

Start date

2010-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

According to basic science research result, Angipars(Semeli) has anti fibrosis effect and postive effect for perfusion. Therer are a few drug can help the patients with Pulomonary hypertension. We decided to evaluate the safety and efficacy of this drug for pulmonary hypertension.

Interventions

Adminstration of oral form of Angipars(Semeli)containing 100 mg active ingredient, three times a day for six months.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Primary pulmonary hypertension. Stable functional class II more than 4 months. Six Minuth Walking Distance(6MWD) between 150-425 meters. Forced Expiratory Volume during one second(FEV1)>40% and pulmonary artery pressure more than 25 mmHg at rest or 30 during activity. FEV1<25% that do not respond to full dose anti infammatory or bronchodilators.

Exclusion criteria

Unstable cardiopulmonary condition in last three months. 6MWD less than 150 meters. Diastolic blood pressure less than 85 mmHg. Bosentan or Prostanoid intake during 3 months before Entering study.

Outcome results