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Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01449253
First received: October 7, 2011
Last updated: January 28, 2013
Last verified: January 2013

October 7, 2011
January 28, 2013
August 2011
July 2013   (final data collection date for primary outcome measure)
  • Echocardiogram [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in pulmonary artery pressures
  • WHO functional classification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in WHO functional classification
  • 6 minute walk test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in 6 minute walk test
  • Pulmonary function test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in Pulmonary function test
  • Visual analog scale for dyspnea [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in Visual analog scale for dyspnea
Same as current
Complete list of historical versions of study NCT01449253 on ClinicalTrials.gov Archive Site
  • Echocardiography measuring pulmonary artery pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in pulmonary artery pressures measured by Echocardiography
  • WHO functional classification [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in WHO functional classification
  • 6 minute walk test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in 6 minute walk test
  • Pulmonary function test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in Pulmonary function test
  • Visual analog scale for dyspnea [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Improvement in Visual analog scale for dyspnea
  • Biochemical markers at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Levels of biomarkers such as Trop T, pro-BNP, uric acid at 3 months and 6 months after starting the drugs
  • Monitoring side effects of the drugs [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately
Same as current
Not Provided
Not Provided
 
Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia

This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.This is to find out when to start combination therapy (sildenafil plus bosentan) in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia.

This is an open label, randomized, interventional study indented to find the efficacy of different treatment regimens in treatment of pulmonary hypertension secondary to lung disease and/or hypoxia. It involves 3 arms, one getting monotherapy with sildenafil for 6 months, 2nd getting bosentan monotherapy initially for 3 months and then combination of sildenafil and bosentan for 3 months, 3rd getting combination sildenafil and bosentan from the beginning for 6 months. The aim is to decide when is the best time to start combination therapy either from start or at the time of drug failure. Improvement will be assessed by change in functional class, pulmonary pressures measured by ECHO, pulmonary function test, six minute walk test and biochemical markers. Lack of randomized trials and Indian data is there on the subject. Also adverse events and serious adverse events will be closely monitored and reported to the ethics committee and DCGI immediately.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia
  • Drug: Sildenafil
    20 mg initially and then increased to 20 mg TDS if there is no fall in BP
  • Drug: Bosentan
    Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD
  • Active Comparator: Monotherapy
    Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months
    Intervention: Drug: Sildenafil
  • Active Comparator: Sequential Therapy
    Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started be added after 3 months. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. Bosentan and sildenafil will be in combination in the last 3 months. No fixed dose combination will be used.
    Interventions:
    • Drug: Sildenafil
    • Drug: Bosentan
  • Active Comparator: Combination therapy
    Bosentan will be started at 62.5mg BD for 4 weeks and then increased to 125mg BD. Sildenafil will be started at 20mg OD and then increased to 20mg TDS if there is no fall in BP. Total duration is of 6 months. No fixed dose combination will be used.
    Interventions:
    • Drug: Sildenafil
    • Drug: Bosentan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Pulmonary artery hypertension diagnosed by doppler echocardiography as mean pulmonary artery pressure 25 mmHg (done in department of cardiology, AIIMS)
  2. Age more than 18 years
  3. Pulmonary artery hypertension due to hypoxia, either chronic obstructive airway disease or diffuse pulmonary lung disease
  4. Willing to consent to participate in the trial
  5. WHO functional class I,II, III

Exclusion Criteria:

  1. WHO functional class IV
  2. Patient participating in any other trial
  3. Concomitant coronary artery disease
  4. Nitrate intake
  5. Liver dysfunction
  6. Pregnancy and lactation -
Both
18 Years and older
No
Contact: Sajal Ajmani, MBBS 919873570408 sajalajmani@gmail.com
India
 
NCT01449253
pulmonary hypertension
No
S.K.SHARMA, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
Not Provided
Principal Investigator: Surendra K. Sharma, MD,Ph.D All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP