NCT01449253

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

October 7, 2011

Last Update Submit

January 28, 2013

Conditions

Pulmonary Hypertension Secondary to Lung Disease and/or Hypoxia

Outcome Measures

Primary Outcomes (5)

  • Echocardiogram

    Improvement in pulmonary artery pressures

    6 months

  • WHO functional classification

    Improvement in WHO functional classification

    6 months

  • 6 minute walk test

    Improvement in 6 minute walk test

    6 months

  • Pulmonary function test

    Improvement in Pulmonary function test

    6 months

  • Visual analog scale for dyspnea

    Improvement in Visual analog scale for dyspnea

    6 months

Secondary Outcomes (7)

  • Echocardiography measuring pulmonary artery pressure

    3 months

  • WHO functional classification

    3 months

  • 6 minute walk test

    3 months

  • Pulmonary function test

    3 months

  • Visual analog scale for dyspnea

    3 months

  • +2 more secondary outcomes

Study Arms (3)

Monotherapy

ACTIVE COMPARATOR

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

Drug: Sildenafil

Sequential Therapy

ACTIVE COMPARATOR

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.

Drug: SildenafilDrug: Bosentan

Combination therapy

ACTIVE COMPARATOR

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.

Drug: SildenafilDrug: Bosentan

Interventions

SildenafilDRUG

20 mg initially and then increased to 20 mg TDS if there is no fall in BP

Combination therapyMonotherapySequential Therapy
BosentanDRUG

Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD

Combination therapySequential Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • WHO functional class IV
  • Patient participating in any other trial
  • Concomitant coronary artery disease
  • Nitrate intake
  • Liver dysfunction
  • Pregnancy and lactation -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute Of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

MeSH Terms

Interventions

Sildenafil CitrateBosentan

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBenzenesulfonamidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPyrimidines

Study Officials

  • Surendra K. Sharma, MD,Ph.D

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sajal Ajmani, MBBS

CONTACT

919873570408sajalajmani@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HOD Medicine

Study Record Dates

First Submitted

October 7, 2011

First Posted

October 10, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

IN(1)