check_circleStudy Completed
Hypertension, essential
Bayer Identifier:
14725
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study of Nifedipine GITS and Candesartan Combination compared to monotherapy in patients with essential hypertension
Trial purpose
The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active ingredient). The drugs – nifedipine GITS and candesartan - which are being investigated are currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimens will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
1381Trial Dates
April 2011 - May 2012Phase
Phase 2Could I Receive a placebo
YesProducts
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Newmarket, L3Y 5G8, Canada | |
Completed | Addlestone, KT15 2BH, United Kingdom | |
Completed | Chesterfield, S40 4AA, United Kingdom | |
Completed | Trowbridge, BA14 8QA, United Kingdom | |
Completed | Bath, BA2 4JT, United Kingdom | |
Completed | Chippenham, SN15 2SB, United Kingdom | |
Completed | Leamington Spa, CV32 4RA, United Kingdom | |
Terminated | Fowey, PL23 1DT, United Kingdom | |
Completed | Penzance, TR18 4JH, United Kingdom | |
Completed | Penzance, TR19 7HX, United Kingdom | |
Completed | Blackpool, FY3 7EN, United Kingdom | |
Completed | Mt. Pleasant, 29464, United States | |
Completed | Dallas, 75230, United States | |
Completed | Jacksonville, 32216, United States | |
Completed | Cincinnati, 45224, United States | |
Completed | Mobile, 36617, United States | |
Completed | Atlanta, 30338, United States | |
Completed | Salisbury, 28144, United States | |
Completed | Charlotte, 28209, United States | |
Completed | Pavia, 27100, Italy | |
Completed | Sassari, 07100, Italy | |
Completed | Chieti, 66013, Italy | |
Terminated | Milano, 20132, Italy | |
Completed | Granada, 18012, Spain | |
Completed | Petrer, 03610, Spain | |
Completed | Peralada, 17491, Spain | |
Completed | Montreal, H4N 2W2, Canada | |
Completed | St. John's, A1A 3R5, Canada | |
Completed | St. John's, A1E 2E2, Canada | |
Completed | Sarnia, N7T 4X3, Canada | |
Completed | Corunna, N0N 1G0, Canada | |
Completed | Langley, V3A 4H9, Canada | |
Completed | Downsview, M3J 1N2, Canada | |
Completed | Seoul, 150-713, Korea, Republic Of | |
Completed | Goyang-si, 411-706, Korea, Republic Of | |
Completed | Seoul, 120-752, Korea, Republic Of | |
Completed | Seoul, 135-720, Korea, Republic Of | |
Completed | Busan, 602-793, Korea, Republic Of | |
Completed | Uijeongbu, 480-130, Korea, Republic Of | |
Terminated | Seoul, 156-707, Korea, Republic Of | |
Completed | Seoul, 156-755, Korea, Republic Of | |
Completed | Seoul, 158 710, Korea, Republic Of | |
Completed | Goyang-si, 410-773, Korea, Republic Of | |
Completed | Wonju-si, 220-701, Korea, Republic Of | |
Completed | Seoul, 152-703, Korea, Republic Of | |
Completed | Seoul, 150-950, Korea, Republic Of | |
Completed | Seoul, 110-744, Korea, Republic Of | |
Completed | Daejeon, 301-723, Korea, Republic Of | |
Completed | Goyang-si, 412-270, Korea, Republic Of | |
Completed | Kaunas, LT-50009, Lithuania | |
Completed | Vilnius, LT-08661, Lithuania | |
Completed | Kaunas, LT-50009, Lithuania | |
Completed | Kaunas, LT-49387, Lithuania | |
Completed | Alytus, LT-62381, Lithuania | |
Completed | Valencia, 46006, Spain | |
Completed | Hostalets de Balenyà, 08550, Spain | |
Completed | Stellenbosch, 7505, South Africa | |
Completed | Roodepoort, 1724, South Africa | |
Completed | Port Elizabeth, 6014, South Africa | |
Completed | Johannesburg, South Africa | |
Completed | Witbank, 1035, South Africa | |
Completed | Pisa, 56124, Italy | |
Terminated | Pavia, 27100, Italy | |
Terminated | Trieste, 34149, Italy | |
Completed | Bologna, 40138, Italy | |
Completed | Perugia, 06129, Italy | |
Completed | Mercato San Severino, 84085, Italy | |
Completed | Durban, 4037, South Africa | |
Terminated | São Paulo, 04025-011, Brazil | |
Terminated | Sao Paulo, 01244-030, Brazil | |
Terminated | Fortaleza, 60120-021, Brazil | |
Terminated | Goiania, 74605-050, Brazil | |
Terminated | Rio de Janeiro, 22271-100, Brazil | |
Terminated | Campinas, 13010-001, Brazil | |
Terminated | Campinas, 13060904, Brazil | |
Terminated | Brasília, 71265 009, Brazil | |
Completed | Bahía Blanca, 8000, Argentina | |
Completed | Zárate, B2800DGH, Argentina | |
Completed | Santa Fe, 3000, Argentina | |
Completed | Buenos Aires, C1425AWC, Argentina | |
Completed | Buenos Aires, C1280AEB, Argentina | |
Completed | Buenos Aires, C1425DES, Argentina | |
Completed | Buenos Aires, C1430AAQ, Argentina | |
Completed | Córdoba, X5002AOQ, Argentina | |
Completed | Rosario, 2000, Argentina | |
Completed | Córdoba, 5000, Argentina | |
Completed | Buenos Aires, C1440AAD, Argentina | |
Completed | Quilmes, Argentina | |
Completed | Rosario, 2000, Argentina | |
Completed | Kiev, 01 151, Ukraine | |
Completed | Kiev, 03680, Ukraine | |
Completed | Kiev, 01151, Ukraine | |
Completed | Zhytomyr, 10002, Ukraine | |
Completed | Kharkiv, 61176, Ukraine | |
Completed | Kiev, 03680, Ukraine | |
Terminated | St. Petersburg, 197022, Russia | |
Terminated | St. Petersburg, 197022, Russia | |
Terminated | Moscow, 117997, Russia | |
Terminated | St. Petersburg, 199106, Russia | |
Terminated | St. Petersburg, 199106, Russia | |
Terminated | Smolensk, 214019, Russia | |
Terminated | St. Petersburg, 197341, Russia | |
Terminated | Moscow, 125284, Russia | |
Terminated | Moscow, 115432, Russia | |
Terminated | St. Petersburg, 195112, Russia | |
Terminated | St Petersburg, 198013, Russia | |
Terminated | St. Petersburg, 196247, Russia | |
Terminated | Moscow, 119048, Russia | |
Completed | Moscow, 119415, Russia | |
Completed | St. Petersburg, 198205, Russia | |
Terminated | St. Petersburg, 195271, Russia | |
Completed | Deurne, 2100, Belgium | |
Completed | HAM, 3545, Belgium | |
Completed | Wetteren, 9230, Belgium | |
Completed | De Pinte, 9840, Belgium | |
Completed | Greenville, 29615, United States | |
Completed | Deerfield Beach, 33321, United States | |
Completed | Valparaiso, 46383, United States | |
Completed | Coral Gables, 33114-4192, United States | |
Completed | Raleigh, 27609, United States | |
Completed | Kiev, 03680, Ukraine | |
Completed | Kiev, 02660, Ukraine | |
Completed | Vinnitsa, 2108, Ukraine | |
Completed | Barcelona, 08036, Spain | |
Terminated | Santiago de Compostela, 15706, Spain | |
Completed | Benidorm, 03503, Spain | |
Terminated | Goyang-Si, 410-719, Korea, Republic Of | |
Terminated | Anyang-si, 431-070, Korea, Republic Of | |
Completed | Seoul, 133-792, Korea, Republic Of | |
Completed | Chungchungbuk-do, 361-711, Korea, Republic Of | |
Terminated | Oviedo, 33013, Spain | |
Completed | Huelva, 21003, Spain | |
Completed | Bath, BA11 2FH, United Kingdom | |
Completed | St Austell, PL26 7RL, United Kingdom | |
Completed | Kiev, 02 091, Ukraine | |
Completed | Dnipropetrovsk, 49060, Ukraine | |
Completed | Zaporizhzhya, 69118, Ukraine | |
Completed | Somerset West, 7130, South Africa | |
Terminated | Petoria, South Africa | |
Completed | Los Angeles, 90057, United States | |
Completed | Salt Lake City, 84121, United States | |
Completed | West Palm Beach, 33409, United States | |
Completed | Philadelphia, 19142, United States | |
Completed | Deerfield Beach, 33441, United States | |
Completed | Harrisburg, 28075, United States | |
Completed | Salt Lake City, 84109, United States | |
Completed | San Antonio, 78205, United States | |
Completed | Kenosha, 53142, United States | |
Completed | London, N5W 6A2, Canada | |
Completed | Toronto, M9V 4B4, Canada | |
Completed | Sarnia, N7T 4X3, Canada | |
Completed | Etobicoke, M8V 3X8, Canada | |
Completed | Toronto, M9W 4L6, Canada | |
Completed | Brampton, L6T 0G1, Canada | |
Completed | Strathroy, N7G 1Y7, Canada | |
Completed | London, N5Y 5K7, Canada | |
Terminated | Glasgow, G20 0XA, United Kingdom | |
Terminated | Glasgow, G20 7LR, United Kingdom | |
Completed | Bath, BA3 2UH, United Kingdom | |
Completed | Coventry, CV6 4DD, United Kingdom | |
Completed | Corrientes, 3400, Argentina | |
Completed | Rosario, 2000, Argentina | |
Completed | Buenos Aires, 1405, Argentina | |
Completed | Ft. Lauderdale, 33309, United States | |
Terminated | Bath, BA2 4BY, United Kingdom | |
Completed | Westbury, BA13 3JD, United Kingdom |
Primary Outcome
- The primary efficacy variable is the change from baseline in mean seated diastolic blood pressure (MSDBP) at Week 8date_rangeTime Frame:Baseline taken at Visit 1; primary outcome variable assesed at 8 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in mean seated systolic blood pressure (MSSBP) at Week 8date_rangeTime Frame:8 weeksenhanced_encryptionNoSafety Issue:
- Control rate at Week 8date_rangeTime Frame:8 weeksenhanced_encryptionNoSafety Issue:
- Response rate at Week 8date_rangeTime Frame:8 weeksenhanced_encryptionNoSafety Issue:
- Peripheral Edemadate_rangeTime Frame:8 weeksenhanced_encryptionYesSafety Issue:
- Time to achieve first BP controldate_rangeTime Frame:8 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
16Additional Information
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