Study concept and design: Thom, Poulter, Patel, Prabhakaran, Stanton, Bots, Reddy, Cidambi, Rodgers.
Acquisition of data: Thom, Field, Patel, Prabhakaran, Stanton, Grobbee, Bots, Rodgers.
Analysis and interpretation of data: Thom, Poulter, Field, Patel, Prabhakaran, Stanton, Grobbee, Bots, Bompoint, Billot, Rodgers.
Drafting of the manuscript: Thom, Prabhakaran, Bots, Billot, Rodgers.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Thom, Poulter, Patel, Bots, Bompoint, Billot.
Obtained funding: Thom, Patel, Rodgers.
Administrative, technical, or material support: Thom, Poulter, Field, Prabhakaran, Stanton, Reddy, Cidambi.
Study supervision: Thom, Poulter, Field, Prabhakaran, Stanton, Grobbee, Bots, Cidambi, Billot, Rodgers.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Thom, Field, and Patel received reimbursement from Dr Reddy’s Laboratories for travel costs related to visiting India for the UMPIRE trial start-up meetings (June 2010) and again for trial site visits (November 2011). Cidambi was Advisor to Dr Reddy’s Laboratories and responsible for the coordination of the project for Dr Reddy’s until April 2010, and continued as advisor to the chairman of Dr Reddy’s until March 2013. Rodgers has received grants from several research charities, national funding agencies, and generic pharmaceutical companies for research on cardiovascular FDC medications. In November 2012, the George Institute for Global Health obtained an exclusive global license for the fixed-dose combinations used in the UMPIRE trial following a decision by Dr Reddy’s Laboratories not to proceed with taking the products to market because of uncertainty in regulatory requirements. No other disclosures were reported.
Funding/Support: The project was funded by the European Commission Seventh Framework Programme (grant 241849). Dr Reddy’s Laboratories (Hyderabad, India) provided the FDCs and supported the trial start-up meetings in London and India.
Role of the Sponsor: The UMPIRE trial was designed and conducted by an investigator-led independent steering committee. Dr Reddy’s Laboratories had a nonvoting member (Cidambi) on the trial steering committee who had a management role in the design and conduct of the study and reviewed the final manuscript. Neither the European Commission nor Dr Reddy’s had any role in the collection, management, analysis and interpretation of the data; they had no role in approval of the manuscript or decision to submit the manuscript for publication. The European Commission had no role in preparation or review of the manuscript.
UMPIRE Collaborative Group: Data and Safety Monitoring Board: Jane Armitage (chair), Yolanda Van der Graaf, Ravindra Pandey. Clinical End-Point Adjudication Committee: Neil Chapman (chair), Ajay Gupta, Michele McGrady, Clara Chow, S. Harikrishnan, Juuso Makinen, Lucy Perry (coordinator), Careen Orosco (clinical safety team), Elvira Perry (clinical safety team). Expert Advisory Board: Kay Tee Khaw (chair), Raj Tandon, B. Soma Raju, Jonathan Morrell, Stéphane Laurent, Emer Shelley, Andrew Tonkin, Tom Gaziano. UMPIRE Collaborative Group: Coordinating office, Imperial College London: Simon Thom (coordinating chief investigator), Neil Poulter (co–principal investigator), Jane Field (project manager), Alison Adderkin (project oversight), Aisha Anjum (trial monitor), Annette Wilson (administration), Joanna Dobson (statistician). Data management and statistical analysis: the George Institute for Global Health, Sydney: Laurent Billot (trial statistician), Severine Bompoint (statistician), Qiang Li (statistician), Dominic Byrne (data manager), Suzanne Steley (data manager). Coordinating Centres: India: The George Institute for Global Health, Hyderabad: Anushka Patel, Abdul Salam, Vinod Patil, Anurag Shrivastava, Sudha Kallakuri, Nityanand Singh, Rama Guggilla, Nitin Pathak, Jitendra Rathore, Bijini Bahuleyan (data manager); Centre for Chronic Disease Control, New Delhi: Dorairaj Prabhakaran, Kavita Singh, Neha Khanna, Sanjay Singh Panwar, Divya Narayanan, Panniyammakal Jeemon; Public Health Foundation of India, New Delhi: K. Srinath Reddy; Dr Reddy’s Laboratories Ltd, Hyderabad: Haranath Robby, Raghu Cidambi. Investigator Sites, India: Raja Babu Panwar, B. K. Gupta, Manoj Kumar, SP Medical College and AG Hospitals, Bikaner; Vivek Chaturvedi, Neeraj Parakh, Sanjay Tyagi, Parul Gupta, G. B. Pant Hospital, Delhi; R. K. Saran, S. K. Dwivedi, Sharad Chandra, Nitin Agarwal, Roma Dixit, Swapnil Dixit, CSM College and Hospital, Lucknow: Bishav Mohan, Naveen Gupta, Rohit Tandon, Shikha Sharma, DMC and Hospital, Ludhiana; SatyendraTewari, Aditya Kapoor, Shalini Sharma, Sanjay Gandhi, PGIMS, Lucknow; Prakash Negi, Rajeev Merwaha, Ravi Kumar, Sanjeev Asotra, Indira Gandhi Medical College, Shimla; Ambuj Roy, Nikhil Tandon, Nitish Naik, Siuli Das, Neeraj Bhatia, All India Institute of Medical Sciences, Delhi; Rajeev Gupta, R. S. Khedar, Bhawani Mishra, Akansha Bhargava, Fortis Escorts Hospital, Jaipur; Manojkumar Rohit, Srinivas Reddy, Samir Malhotra, Shyambalaji Achuthan, Nusrat Shafiq, Postgraduate Institute of Medical Education and Research, Chandigarh; N. Chidambaram, R. Umarani, D. R. Karthikeyan, K. Palaniappan, Annamali University, Annamali Nagar; P. P. Mohanan, Divin Davies, West Fort Hi-tech Hospital, Thrissur; S. Harikrishnan, G. Sanjay, Suresh Babu, Sree Chitra Tirunal Institute for Medical Science and Technology, Trivandrum; Abraham Oomman, F. M. Saleem, R. Kannan, V. Sivasankaran, K. Balamurali, Ramana Maharishi Rangammal Hospital, Tiruvannamalai; Ashok Kumar Dash, Kalyana Chakravarthy, J. Prafullitha, G. Venkat Prasad, Ashok Kumar Odela, Global Hospitals, Hyderabad; M. Bhaskara Rao, Kodem Damodra Rao, Prathap Chandra Bose, Padmakumari, Department of Cardiology, Care Hospital, Vishakapatnam; Golla Nagendra Prasad, Anand Kannaiyan, Sowmya Joy, Gayathri, Frontier Lifeline, Chennai; G. Venkateshwara Reddy, Malladi Srinivasa Rao, Andhra Medical College, King George Hospital, Vishakapatnam; Milind A. Gadkari, Tapan Pillay, Amol Kshirsagar, Sheetal Karwa, Department of Cardiology, KEM Hospital, Pune; P. V. Raghava Sarma, J. Prahbakar Patro, S. Anil Kumar, Anjan Kumar, Satish Kumar, Nagamalleswara Rao, Lalitha Super Specialties Hospitals, Guntur; Byrapaneni Ramesh Babu, Shasheendra, Murali, Asra Farhana, Kavitha, Priyanka, Peddireddy Jyothsna, Neena Reddy, Medwin Hospital, Hyderabad; Sanjay Mehrotra, Arun Ramarao More, Myfouse Begum, G. Nazia, R. Karthikeyan., Narayana Hrudayala, Bangalore. Satej S Janorkar, Ms. Nikitha Yadav, Deenanath Mangeshkar Hospital and Research Centre, Pune; Damera Seshagiri Rao, Amar Narayan Patnaik, J. L. N. Varma, Nizam’s Institute of Medical Sciences, Hyderabad; Sindhu Joshi, Govinda Pulagam, Madhuri Mahajan, M. Narahari, Mahavir Hospital and Research Centre, Hyderabad; Ballakaere Jayaram Subhash, Sandeep, Madan Ramesh, Atiqulla Shariff, G. Parthasarathi, Jagadguru Sri Shirvarathreeshwara Medical College and Hospital, Mysore; Suhas P. Hardas, Nilesh Savant, Amruta Patil, Ruby Hall Clinic, Pune; Tilak Suvarna, Nishan Sirodariya, Archana Chavan, John Mozhumannil, Hitakshi Trivedi, Asian Heart Institute and Research Centre, Mumbai; K. Joel Nesaraj, S. Rajasekaran, Rufus Demel, M. Nijanth, Bethesda Hospital, Ambur. Investigator Sites, Europe: Alice Stanton (principal investigator), Brendan McAdam, David Williams, Eamon Dolan, Liam Kavanagh, Ursula Quinn, Lelane Vanderpoel, Benita Maguire, Kathleen Shortall, Margaret McGrath, Ann Collins, Sandra McHugh, Barbara Gallagher, Royal College of Surgeons in Ireland, Beaumont and Connolly Hospitals, Dublin, Ireland; Filomena Paciello (principal investigator), Rebecca James, Jill Bunker, Wendy Callister, Natesha Henry-Mitchell, Judy Mackay, Clinical Investigation Unit, International Centre for Circulatory Health, Imperial College NHS Trust, London, England; Diederick E. Grobbee (principal investigator), Michiel L. Bots (co–principal investigator), Melvin Lafeber, Marcel van Dijk, Wilco Spiering, Lydeke Zwart, Gerry Van Hemert, Karen Menninga, Fien Stern, Lizeth Vendrig, University Medical Center Utrecht, Utrecht, the Netherlands. SPACE Collaboration: Anthony Rodgers (chair), Anushka Patel (deputy chair), Ruth Webster (coordinator); membership, see www.spacecollaboration.org. The IMPACT trial was the first of the trials designed by the SPACE collaboration and provided the basis for the design of the sister trials, Kanyini GAP and UMPIRE.
Previous Presentation: Presented in part at the American Heart Association Scientific Sessions, Los Angeles, California, on November 5, 2012.
Additional Contributions: We are indebted to the 2138 individuals who volunteered as participants in this trial.
Correction: This article was corrected on September 25, 2013, to correct misspelled and omitted names in the UMPIRE group.