Lesinurad and Allopurinol Combination Extension Study in Gout
Sponsor
Ardea Biosciences, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01808131
Collaborator
(none)
717
208
2
45
3.4
0.1
Study Details
Study Description
Brief Summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with allopurinol over a long-term timeframe.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with allopurinol in subjects who completed the double-blind treatment period in Studies RDEA594-301 and RDEA594-302.
Study Design
Study Type:
Interventional
Actual Enrollment
:
717 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Long-Term Extension Study of Lesinurad in Combination With Allopurinol for Subjects Completing an Efficacy and Safety Study of Lesinurad and Allopurinol
Study Start Date
:
Feb 1, 2013
Actual Primary Completion Date
:
Aug 1, 2016
Actual Study Completion Date
:
Nov 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: lesinurad 200 mg + allopurinol
|
Drug: Lesinurad
Tablets, 200 mg QD
|
| Experimental: lesinurad 400 mg + allopurinol Patients on lesinurad 400 mg had their dose changed to lesinurad 200 mg after implementation of protocol amendment 4, dated 07 October 2015. |
Drug: Lesinurad
Tablets, 400 mg QD
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with an sUA level that is < 6.0 mg/dL [up to a total of 5 years]
Secondary Outcome Measures
- Resolution of at least 1 target tophi [Up to Month 12]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity.
-
Subject completed the double-blind treatment period in either Study RDEA594-301 or RDEA594-302 and was actively receiving and tolerating study medication (lesinurad or placebo) and allopurinol at the Month 12 visit.
-
Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth
Exclusion Criteria:
- Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35213 | |
| 2 | Birmingham | Alabama | United States | 35235 | |
| 3 | Birmingham | Alabama | United States | 35294 | |
| 4 | Gulf Shores | Alabama | United States | 36542 | |
| 5 | Pinson | Alabama | United States | 35126 | |
| 6 | Glendale | Arizona | United States | 85308 | |
| 7 | Mesa | Arizona | United States | 85203 | |
| 8 | Peoria | Arizona | United States | 85381 | |
| 9 | Little Rock | Arkansas | United States | 72206 | |
| 10 | Little Rock | Arkansas | United States | 72211 | |
| 11 | Little Rock | Arkansas | United States | 72223 | |
| 12 | Anaheim | California | United States | 92805 | |
| 13 | Gold River | California | United States | 95670 | |
| 14 | Irvine | California | United States | 92618 | |
| 15 | Roseville | California | United States | 95661 | |
| 16 | Sacramento | California | United States | 95825 | |
| 17 | San Diego | California | United States | 92108 | |
| 18 | San Leandro | California | United States | 94578 | |
| 19 | San Ramon | California | United States | 94582 | |
| 20 | Colorado Springs | Colorado | United States | 80918 | |
| 21 | Colorado Springs | Colorado | United States | 80922 | |
| 22 | Denver | Colorado | United States | 80220 | |
| 23 | Englewood | Colorado | United States | 80113 | |
| 24 | Brandon | Florida | United States | 33511 | |
| 25 | Brooksville | Florida | United States | 34601 | |
| 26 | Jacksonville | Florida | United States | 32205 | |
| 27 | Jupiter | Florida | United States | 33458 | |
| 28 | Miami | Florida | United States | 33125 | |
| 29 | Miami | Florida | United States | 33169 | |
| 30 | Miami | Florida | United States | 33186 | |
| 31 | Ocala | Florida | United States | 34474 | |
| 32 | Pembroke Pines | Florida | United States | 33027 | |
| 33 | Plant City | Florida | United States | 33563 | |
| 34 | Port Orange | Florida | United States | 32127 | |
| 35 | Tampa | Florida | United States | 33607 | |
| 36 | Tampa | Florida | United States | 33634 | |
| 37 | Vero Beach | Florida | United States | 32960 | |
| 38 | Atlanta | Georgia | United States | 30308 | |
| 39 | Atlanta | Georgia | United States | 30328 | |
| 40 | Augusta | Georgia | United States | 30909 | |
| 41 | Conyers | Georgia | United States | 30013 | |
| 42 | Johns Creek | Georgia | United States | 30097 | |
| 43 | Roswell | Georgia | United States | 30075 | |
| 44 | Savannah | Georgia | United States | 31406 | |
| 45 | Honolulu | Hawaii | United States | 96814 | |
| 46 | Idaho Falls | Idaho | United States | 83404 | |
| 47 | Meridian | Idaho | United States | 83642 | |
| 48 | Meridian | Idaho | United States | 83646 | |
| 49 | Gurnee | Illinois | United States | 60031 | |
| 50 | Cedar Rapids | Iowa | United States | 52403 | |
| 51 | Elizabethtown | Kentucky | United States | 42701 | |
| 52 | Lexington | Kentucky | United States | 40503 | |
| 53 | Paducah | Kentucky | United States | 42003 | |
| 54 | Metairie | Louisiana | United States | 70002 | |
| 55 | Metairie | Louisiana | United States | 70006 | |
| 56 | Natchitoches | Louisiana | United States | 71457 | |
| 57 | Cumberland | Maryland | United States | 21502 | |
| 58 | Worcester | Massachusetts | United States | 01605 | |
| 59 | Ann Arbor | Michigan | United States | 48109 | |
| 60 | Flint | Michigan | United States | 48504 | |
| 61 | Kalamazoo | Michigan | United States | 49009 | |
| 62 | Southfield | Michigan | United States | 48034 | |
| 63 | Traverse City | Michigan | United States | 49684 | |
| 64 | Hazelwood | Missouri | United States | 63042 | |
| 65 | Jefferson City | Missouri | United States | 65109 | |
| 66 | Kansas City | Missouri | United States | 64114 | |
| 67 | Saint Louis | Missouri | United States | 63117 | |
| 68 | St. Louis | Missouri | United States | 63117 | |
| 69 | Washington | Missouri | United States | 63090 | |
| 70 | Omaha | Nebraska | United States | 68114 | |
| 71 | Reno | Nevada | United States | 89502 | |
| 72 | Albuquerque | New Mexico | United States | 87106 | |
| 73 | Brooklyn | New York | United States | 11201 | |
| 74 | Hartsdale | New York | United States | 10530 | |
| 75 | New York | New York | United States | 10036 | |
| 76 | Calabash | North Carolina | United States | 28467 | |
| 77 | Charlotte | North Carolina | United States | 28210 | |
| 78 | Greensboro | North Carolina | United States | 27405 | |
| 79 | Hickory | North Carolina | United States | 28602 | |
| 80 | Raleigh | North Carolina | United States | 27609 | |
| 81 | Shelby | North Carolina | United States | 28150 | |
| 82 | Shelby | North Carolina | United States | 28152 | |
| 83 | Wilmington | North Carolina | United States | 28401 | |
| 84 | Winston-Salem | North Carolina | United States | 27103 | |
| 85 | Fargo | North Dakota | United States | 58103 | |
| 86 | Cincinnati | Ohio | United States | 45224 | |
| 87 | Cincinnati | Ohio | United States | 45242 | |
| 88 | Cleveland | Ohio | United States | 44122 | |
| 89 | Colombus | Ohio | United States | 43235 | |
| 90 | Dayton | Ohio | United States | 45417 | |
| 91 | Dayton | Ohio | United States | 45424 | |
| 92 | Franklin | Ohio | United States | 45005 | |
| 93 | Middleburg Heights | Ohio | United States | 44130 | |
| 94 | Perrysburg | Ohio | United States | 43551 | |
| 95 | Willoughby Hills | Ohio | United States | 44094 | |
| 96 | Oklahoma City | Oklahoma | United States | 73103 | |
| 97 | Tulsa | Oklahoma | United States | 74104 | |
| 98 | Portland | Oregon | United States | 97220 | |
| 99 | Altoona | Pennsylvania | United States | 16602 | |
| 100 | Clairton | Pennsylvania | United States | 15025 | |
| 101 | Duncansville | Pennsylvania | United States | 16635 | |
| 102 | Indiana | Pennsylvania | United States | 15701 | |
| 103 | Jenkintown | Pennsylvania | United States | 19046 | |
| 104 | McMurray | Pennsylvania | United States | 15317 | |
| 105 | Pittsburgh | Pennsylvania | United States | 15206 | |
| 106 | Scottdale | Pennsylvania | United States | 15683 | |
| 107 | Columbia | South Carolina | United States | 29204 | |
| 108 | Mount Pleasant | South Carolina | United States | 29464 | |
| 109 | Myrtle Beach | South Carolina | United States | 29588 | |
| 110 | Rock Hill | South Carolina | United States | 29732 | |
| 111 | Spartanburg | South Carolina | United States | 29303 | |
| 112 | Union | South Carolina | United States | 29379 | |
| 113 | Knoxville | Tennessee | United States | 37919 | |
| 114 | Knoxville | Tennessee | United States | 37923 | |
| 115 | Memphis | Tennessee | United States | 38119 | |
| 116 | Spring Hill | Tennessee | United States | 37174 | |
| 117 | Austin | Texas | United States | 78758 | |
| 118 | Dallas | Texas | United States | 75218 | |
| 119 | Fort Worth | Texas | United States | 76135 | |
| 120 | Houston | Texas | United States | 77043 | |
| 121 | Houston | Texas | United States | 77062 | |
| 122 | Houston | Texas | United States | 77074 | |
| 123 | Houston | Texas | United States | 77099 | |
| 124 | Irving | Texas | United States | 75061 | |
| 125 | Kingwood | Texas | United States | 77339 | |
| 126 | Nassau Bay | Texas | United States | 77058 | |
| 127 | Plano | Texas | United States | 75024 | |
| 128 | Plano | Texas | United States | 75075 | |
| 129 | San Angelo | Texas | United States | 76904 | |
| 130 | San Antonio | Texas | United States | 78209 | |
| 131 | San Antonio | Texas | United States | 78215 | |
| 132 | San Antonio | Texas | United States | 78229 | |
| 133 | Sealy | Texas | United States | 77474 | |
| 134 | Sugar Land | Texas | United States | 77479 | |
| 135 | Waco | Texas | United States | 76710 | |
| 136 | Bountiful | Utah | United States | 84010 | |
| 137 | Layton | Utah | United States | 84041 | |
| 138 | Salt Lake City | Utah | United States | 84102 | |
| 139 | West Jordan | Utah | United States | 84088 | |
| 140 | Danville | Virginia | United States | 24541 | |
| 141 | Manassas | Virginia | United States | 20110 | |
| 142 | Midlothian | Virginia | United States | 23114 | |
| 143 | Richmond | Virginia | United States | 23219 | |
| 144 | Richmond | Virginia | United States | 23233 | |
| 145 | Richmond | Virginia | United States | 23235 | |
| 146 | Virginia Beach | Virginia | United States | 23462 | |
| 147 | Olympia | Washington | United States | 98502 | |
| 148 | Seattle | Washington | United States | 98104 | |
| 149 | Spokane | Washington | United States | 99208 | |
| 150 | Tacoma | Washington | United States | 98405 | |
| 151 | Morgantown | West Virginia | United States | 26505 | |
| 152 | Milwaukee | Wisconsin | United States | 53226 | |
| 153 | Herston | Queensland | Australia | 4029 | |
| 154 | Clayton | Victoria | Australia | 3168 | |
| 155 | Heidelberg West | Victoria | Australia | 3081 | |
| 156 | Brisbane | Australia | QLD 4152 | ||
| 157 | Woodville South | Australia | 5011 | ||
| 158 | Genk | Belgium | 3600 | ||
| 159 | Kortrijk | Belgium | 8500 | ||
| 160 | Lommel | Belgium | 3920 | ||
| 161 | Yvoir | Belgium | 5530 | ||
| 162 | Coquitlam | British Columbia | Canada | V3K 3P4 | |
| 163 | Penticton | British Columbia | Canada | V2A 5C8 | |
| 164 | Kitchener | Ontario | Canada | N2M 5N6 | |
| 165 | London | Ontario | Canada | N6A 5R8 | |
| 166 | Toronto | Ontario | Canada | M9W4L6 | |
| 167 | Québec City | Quebec | Canada | G1V 3M7 | |
| 168 | Eichstätt | Bayern | Germany | 85072 | |
| 169 | Goch | Nordrhein-Westfalen | Germany | 47574 | |
| 170 | Dresden | Sachsen | Germany | 01069 | |
| 171 | Dresden | Sachsen | Germany | 01307 | |
| 172 | Kamenz | Sachsen | Germany | 01917 | |
| 173 | Leipzig | Sachsen | Germany | 04109 | |
| 174 | Grafton | Auckland | New Zealand | 1023 | |
| 175 | Otahuhu | Auckland | New Zealand | 2025 | |
| 176 | Beckenham | Christchurch | New Zealand | 8024 | |
| 177 | Birkinhead | New Zealand | 0626 | ||
| 178 | Hamilton | New Zealand | 3204 | ||
| 179 | Rotorua | New Zealand | 3010 | ||
| 180 | Tauranga | New Zealand | 3143 | ||
| 181 | Krakow | Malopolskie | Poland | 30-510 | |
| 182 | Katowice | Slaskie | Poland | 40-954 | |
| 183 | Konskie | Swietokrzyskie | Poland | 26-200 | |
| 184 | Poznan | Wielkopolskie | Poland | 60-773 | |
| 185 | Warminsko-mazurskie | Poland | 82-300 | ||
| 186 | Warszawa | Poland | 01-192 | ||
| 187 | Newlands | Durban | South Africa | 4037 | |
| 188 | Silverglen | Durban | South Africa | 4092 | |
| 189 | Newtown | Johannesburg | South Africa | 2113 | |
| 190 | Parktown | Johannesburg | South Africa | 2193 | |
| 191 | Radiokop | Johannesburg | South Africa | 1724 | |
| 192 | Sowento | Johannesburg | South Africa | 1804 | |
| 193 | Thabazimbi | Limpopo | South Africa | 0380 | |
| 194 | Muckleneuk | Pretoria | South Africa | 0002 | |
| 195 | Durban | South Africa | 4001 | ||
| 196 | Paarl | South Africa | 7646 | ||
| 197 | Rondebosch | South Africa | 7700 | ||
| 198 | Stellenbosch | South Africa | 7600 | ||
| 199 | Witbank | South Africa | 1035 | ||
| 200 | Worcester | South Africa | 6850 | ||
| 201 | Merida | Badajoz | Spain | 06800 | |
| 202 | La Coruna | Spain | 15006 | ||
| 203 | Lausanne | Vaud | Switzerland | CH-1011 | |
| 204 | Kharkiv | Ukraine | 61157 | ||
| 205 | Kharkiv | Ukraine | 61176 | ||
| 206 | Kyiv | Ukraine | 01680 | ||
| 207 | Poltava | Ukraine | 36011 | ||
| 208 | Vinnytsia | Ukraine | 21018 |
Sponsors and Collaborators
- Ardea Biosciences, Inc.
Investigators
- Study Director: Nihar Bhakta, MD, Ardea Biosciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01808131
Other Study ID Numbers:
- RDEA594-306
- 2012-004389-16
First Posted:
Mar 11, 2013
Last Update Posted:
Jan 24, 2017
Last Verified:
Jan 1, 2017