A study to compare the beneficial effect and safety of tadalafil compared to sildenafil in pulmonary hypertensive patients due to lung disease

Phase 4

• Conditions: Health Condition 1: I272- Other secondary pulmonary hypertension

• Registration Number: CTRI/2024/06/069470
• Lead Sponsor: Midhun Sakravarthy J

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients of either gender

2. Aged more than 18 years

3. Patients who are diagnosed with Pulmonary Hypertension based on 2D-Echo having

any pulmonary etiology (Group 3) not on any pulmonary vasodilator therapy and

WHO Functional Class II-III

Exclusion Criteria

1. Impaired hepatic Function with elevated AST or ALT levels = 3 times the upper limit

of normal

2. Patient with history of renal disease or impaired kidney function with elevated Serum

creatinine

3. Pregnant and lactating women

4. Patients requiring nitrate therapy for any clinical indication.

5. Contraindication to Tadalafil or Sildenafil use including allergy to any PDE-5

inhibitor, anatomical deformations of the penis, sickle cell anemia, multiple

myeloma, leukemia, bleeding disorders, active peptic ulcer disease, retinitis

pigmentosa or other retinal disorders

6. The use or anticipated use of any of the following drugs: any nitrate, protease

inhibitor, anti-fungal agent and/or rifampin, or doxazosin.

7. Known malignancies

8. Known other heart related co-morbid

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in 2D-Echo parameters (RVSP, TRJET) <br/ ><br>2. Change in Six-Minute Walk distance TestTimepoint: 1.0,3rd and 6th month <br/ ><br>2.0,3rd and 6th month

Secondary Outcome Measures

Name	Time	Method
1.Arterial Blood Gas(PaO2) <br/ ><br>2.Change in WHO-Functional class for pulmonary hypertensive patients <br/ ><br>3.Adverse reactionsTimepoint: 1.0,3rd and 6th month <br/ ><br>2.0,3rd and 6th month <br/ ><br>3.0,3rd and 6th month