Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension

NCT01353274 | Completed Results

• 1 other identifier: 1235.38
• Study Type: observational
• Target: 1,157
• Locations: 1 country
• Sites: 254

Brief Summary

Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence of Drug-related Adverse Events

  Number of patients with drug-related adverse events

  12 months

Secondary Outcomes (4)

• Change From Baseline in Systolic Blood Pressure (SBP)

  after 1, 2, 3, 6, 12 months

• Change From Baseline in Diastolic Blood Pressure (DBP)

  after 1, 2, 3, 6, 12 months

• Proportion of Patients Who Achieved the Target BP

  after 1, 2, 3, 6, 12 months

• Proportion of Patients Who Normalised Their BP

  after 1, 2, 3, 6, 12 months

Study Arms (1)

Patients with hypertension

Drug: Micamlo

Interventions

Micamlo DRUG

Telmisartan plus Amlodipine T40/A5

Patients with hypertension

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1200

You may qualify if:

• \- Male and Female patients with hypertension who did not receive of MICAMLO Combination Tablets AP before the start of the study

You may not qualify if:

• Patients with a history of hypersensitivity to any ingredient of Micamlo Combination Tablets AP and dihydropyridine derivatives
• Pregnant woman or possibly pregnant woman
• Patients with extremely poor bile secretion or patients with serious hepatic disorder

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (254)

Boehringer Ingelheim Investigational Site 199

Akaiwa, Japan

Location

Boehringer Ingelheim Investigational Site 83

Akishima, Japan

Location

Boehringer Ingelheim Investigational Site 25

Akita, Japan

Location

Boehringer Ingelheim Investigational Site 188

Amagasaki, Japan

Location

Boehringer Ingelheim Investigational Site 116

Anamizu-machi, Japan

Location

Boehringer Ingelheim Investigational Site 212

Anan, Japan

Location

Boehringer Ingelheim Investigational Site 145

Anjo, Japan

Location

Boehringer Ingelheim Investigational Site 11

Aomori, Japan

Location

Boehringer Ingelheim Investigational Site 12

Aomori, Japan

Location

Boehringer Ingelheim Investigational Site 192

Arita, Japan

Location

Boehringer Ingelheim Investigational Site 7

Asahikawa, Japan

Location

Boehringer Ingelheim Investigational Site 104

Atsugi, Japan

Location

Boehringer Ingelheim Investigational Site 57

Chiba, Japan

Location

Boehringer Ingelheim Investigational Site 58

Chiba, Japan

Location

Boehringer Ingelheim Investigational Site 232

Chikuzen-machi, Japan

Location

Boehringer Ingelheim Investigational Site 143

Chita, Japan

Location

Boehringer Ingelheim Investigational Site 23

Daisen, Japan

Location

Boehringer Ingelheim Investigational Site 24

Daisen, Japan

Location

Boehringer Ingelheim Investigational Site 10

Date, Japan

Location

Boehringer Ingelheim Investigational Site 90

Fuchū, Japan

Location

Boehringer Ingelheim Investigational Site 52

Fujimino, Japan

Location

Boehringer Ingelheim Investigational Site 129

Fujinomiya, Japan

Location

Boehringer Ingelheim Investigational Site 103

Fujisawa, Japan

Location

Boehringer Ingelheim Investigational Site 158

Fukuchiyama, Japan

Location

Boehringer Ingelheim Investigational Site 224

Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 225

Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site 29

Fukushima, Japan

Location

Boehringer Ingelheim Investigational Site 13

Hachinohe, Japan

Location

Boehringer Ingelheim Investigational Site 130

Hamamatsu, Japan

Location

Boehringer Ingelheim Investigational Site 131

Hamamatsu, Japan

Location

Boehringer Ingelheim Investigational Site 219

Handa, Japan

Location

Boehringer Ingelheim Investigational Site 171

Hannan, Japan

Location

Boehringer Ingelheim Investigational Site 204

Hatsukaichi, Japan

Location

Boehringer Ingelheim Investigational Site 208

Higashihiroshima, Japan

Location

Boehringer Ingelheim Investigational Site 5

Higashikagura-cho, Japan

Location

Boehringer Ingelheim Investigational Site 66

Higashimurayama, Japan

Location

Boehringer Ingelheim Investigational Site 151

Hikone, Japan

Location

Boehringer Ingelheim Investigational Site 179

Himeji, Japan

Location

Boehringer Ingelheim Investigational Site 180

Himeji, Japan

Location

Boehringer Ingelheim Investigational Site 181

Himeji, Japan

Location

Boehringer Ingelheim Investigational Site 169

Hirakata, Japan

Location

Boehringer Ingelheim Investigational Site 170

Hirakata, Japan

Location

Boehringer Ingelheim Investigational Site 201

Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site 202

Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site 203

Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site 38

Hitachi-Naka, Japan

Location

Boehringer Ingelheim Investigational Site 37

Hitachiota, Japan

Location

Boehringer Ingelheim Investigational Site 62

Ichikawa, Japan

Location

Boehringer Ingelheim Investigational Site 17

Ichinoseki, Japan

Location

Boehringer Ingelheim Investigational Site 223

Iizuka, Japan

Location

Boehringer Ingelheim Investigational Site 175

Ikeda, Japan

Location

Boehringer Ingelheim Investigational Site 238

Iki, Japan

Location

Boehringer Ingelheim Investigational Site 63

IKisarazu, Japan

Location

Boehringer Ingelheim Investigational Site 191

Ikoma, Japan

Location

Boehringer Ingelheim Investigational Site 111

Imizu, Japan

Location

Boehringer Ingelheim Investigational Site 189

Itami, Japan

Location

Boehringer Ingelheim Investigational Site 253

Itoman, Japan

Location

Boehringer Ingelheim Investigational Site 233

Itoshima, Japan

Location

Boehringer Ingelheim Investigational Site 252

Izumi, Japan

Location

Boehringer Ingelheim Investigational Site 249

Kagoshima, Japan

Location

Boehringer Ingelheim Investigational Site 250

Kagoshima, Japan

Location

Boehringer Ingelheim Investigational Site 125

Kakamigahara, Japan

Location

Boehringer Ingelheim Investigational Site 229

Kama, Japan

Location

Boehringer Ingelheim Investigational Site 152

Kameoka, Japan

Location

Boehringer Ingelheim Investigational Site 241

Kamiamakusa, Japan

Location

Boehringer Ingelheim Investigational Site 242

Kamiamakusa, Japan

Location

Boehringer Ingelheim Investigational Site 22

Kamimachi, Japan

Location

Boehringer Ingelheim Investigational Site 113

Kanazawa, Japan

Location

Boehringer Ingelheim Investigational Site 114

Kanazawa, Japan

Location

Boehringer Ingelheim Investigational Site 237

Kanzaki, Japan

Location

Boehringer Ingelheim Investigational Site 144

Kariya, Japan

Location

Boehringer Ingelheim Investigational Site 33

Kasama, Japan

Location

Boehringer Ingelheim Investigational Site 34

Kasama, Japan

Location

Boehringer Ingelheim Investigational Site 137

Kasugai, Japan

Location

Boehringer Ingelheim Investigational Site 138

Kasugai, Japan

Location

Boehringer Ingelheim Investigational Site 48

Kasukabe, Japan

Location

Boehringer Ingelheim Investigational Site 49

Kasukabe, Japan

Location

Boehringer Ingelheim Investigational Site 177

Katō, Japan

Location

Boehringer Ingelheim Investigational Site 178

Katō, Japan

Location

Boehringer Ingelheim Investigational Site 117

Katsuyama, Japan

Location

Boehringer Ingelheim Investigational Site 121

Kawachi-Nagano, Japan

Location

Boehringer Ingelheim Investigational Site 51

Kawaguchi, Japan

Location

Boehringer Ingelheim Investigational Site 100

Kawasaki, Japan

Location

Boehringer Ingelheim Investigational Site 101

Kawasaki, Japan

Location

Boehringer Ingelheim Investigational Site 43

Kiryū, Japan

Location

Boehringer Ingelheim Investigational Site 176

Kita-ku, Japan

Location

Boehringer Ingelheim Investigational Site 15

Kitakami, Japan

Location

Boehringer Ingelheim Investigational Site 226

Kitakyushu, Japan

Location

Boehringer Ingelheim Investigational Site 227

Kitakyushu, Japan

Location

Boehringer Ingelheim Investigational Site 4

Kitami, Japan

Location

Boehringer Ingelheim Investigational Site 183

Kobe, Japan

Location

Boehringer Ingelheim Investigational Site 184

Kobe, Japan

Location

Boehringer Ingelheim Investigational Site 185

Kobe, Japan

Location

Boehringer Ingelheim Investigational Site 186

Kobe, Japan

Location

Boehringer Ingelheim Investigational Site 187

Kobe, Japan

Location

Boehringer Ingelheim Investigational Site 220

Kochi, Japan

Location

Boehringer Ingelheim Investigational Site 56

Koshigaya, Japan

Location

Boehringer Ingelheim Investigational Site 193

Kotoura-cho, Japan

Location

Boehringer Ingelheim Investigational Site 240

Kotouracho, Japan

Location

Boehringer Ingelheim Investigational Site 30

Kōriyama, Japan

Location

Boehringer Ingelheim Investigational Site 53

Kumagaya, Japan

Location

Boehringer Ingelheim Investigational Site 243

Kumamoto, Japan

Location

Boehringer Ingelheim Investigational Site 196

Kurashiki, Japan

Location

Boehringer Ingelheim Investigational Site 205

Kure, Japan

Location

Boehringer Ingelheim Investigational Site 206

Kure, Japan

Location

Boehringer Ingelheim Investigational Site 230

Kurume, Japan

Location

Boehringer Ingelheim Investigational Site 231

Kurume, Japan

Location

Boehringer Ingelheim Investigational Site 149

Kusatsu, Japan

Location

Boehringer Ingelheim Investigational Site 9

Kushiro, Japan

Location

Boehringer Ingelheim Investigational Site 153

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 154

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 155

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 156

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 157

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site 99

Matsuda-machi, Japan

Location

Boehringer Ingelheim Investigational Site 64

Matsudo, Japan

Location

Boehringer Ingelheim Investigational Site 65

Matsudo, Japan

Location

Boehringer Ingelheim Investigational Site 195

Matsue, Japan

Location

Boehringer Ingelheim Investigational Site 119

Matsumoto, Japan

Location

Boehringer Ingelheim Investigational Site 120

Matsumoto, Japan

Location

Boehringer Ingelheim Investigational Site 234

Matsuura, Japan

Location

Boehringer Ingelheim Investigational Site 216

Matsuyama, Japan

Location

Boehringer Ingelheim Investigational Site 217

Matsuyama, Japan

Location

Boehringer Ingelheim Investigational Site 148

Matsuzaka, Japan

Location

Boehringer Ingelheim Investigational Site 207

Mihara, Japan

Location

Boehringer Ingelheim Investigational Site 122

Minamiminowa-mura, Japan

Location

Boehringer Ingelheim Investigational Site 248

Miyazaki, Japan

Location

Boehringer Ingelheim Investigational Site 126

Mizunami, Japan

Location

Boehringer Ingelheim Investigational Site 60

Mobara, Japan

Location

Boehringer Ingelheim Investigational Site 61

Mobara, Japan

Location

Boehringer Ingelheim Investigational Site 16

Morioka, Japan

Location

Boehringer Ingelheim Investigational Site 27

Murayama, Japan

Location

Boehringer Ingelheim Investigational Site 105

Nagaoka, Japan

Location

Boehringer Ingelheim Investigational Site 106

Nagaoka, Japan

Location

Boehringer Ingelheim Investigational Site 235

Nagasaki, Japan

Location

Boehringer Ingelheim Investigational Site 254

Nago, Japan

Location

Boehringer Ingelheim Investigational Site 139

Nagoya, Japan

Location

Boehringer Ingelheim Investigational Site 140

Nagoya, Japan

Location

Boehringer Ingelheim Investigational Site 141

Nagoya, Japan

Location

Boehringer Ingelheim Investigational Site 142

Nagoya, Japan

Location

Boehringer Ingelheim Investigational Site 228

Nakagawamachi, Japan

Location

Boehringer Ingelheim Investigational Site 39

Nakagawamachi, Japan

Location

Boehringer Ingelheim Investigational Site 245

Nakatsu, Japan

Location

Boehringer Ingelheim Investigational Site 127

Nakatsugawa, Japan

Location

Boehringer Ingelheim Investigational Site 59

Narita, Japan

Location

Boehringer Ingelheim Investigational Site 18

Natori, Japan

Location

Boehringer Ingelheim Investigational Site 8

Nayoro, Japan

Location

Boehringer Ingelheim Investigational Site 246

Nichinan, Japan

Location

Boehringer Ingelheim Investigational Site 31

Nihonmatsu, Japan

Location

Boehringer Ingelheim Investigational Site 107

Niigata, Japan

Location

Boehringer Ingelheim Investigational Site 200

Niimi, Japan

Location

Boehringer Ingelheim Investigational Site 6

Nikki-cho, Japan

Location

Boehringer Ingelheim Investigational Site 128

Nishiizu-cho, Japan

Location

Boehringer Ingelheim Investigational Site 182

Nishinomiya, Japan

Location

Boehringer Ingelheim Investigational Site 112

Nomi, Japan

Location

Boehringer Ingelheim Investigational Site 134

Numazu, Japan

Location

Boehringer Ingelheim Investigational Site 197

Okayama, Japan

Location

Boehringer Ingelheim Investigational Site 198

Okayama, Japan

Location

Boehringer Ingelheim Investigational Site 14

Omamachi, Japan

Location

Boehringer Ingelheim Investigational Site 159

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 160

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 161

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 162

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 163

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 164

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 165

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 166

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 167

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 168

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site 40

Oyama, Japan

Location

Boehringer Ingelheim Investigational Site 26

Ōdate, Japan

Location

Boehringer Ingelheim Investigational Site 124

Ōgaki, Japan

Location

Boehringer Ingelheim Investigational Site 244

Ōita, Japan

Location

Boehringer Ingelheim Investigational Site 239

Ōmura, Japan

Location

Boehringer Ingelheim Investigational Site 35

Ryūgasaki, Japan

Location

Boehringer Ingelheim Investigational Site 236

Saga, Japan

Location

Boehringer Ingelheim Investigational Site 102

Sagamihara, Japan

Location

Boehringer Ingelheim Investigational Site 46

Saitama, Japan

Location

Boehringer Ingelheim Investigational Site 47

Saitama, Japan

Location

Boehringer Ingelheim Investigational Site 172

Sakai, Japan

Location

Boehringer Ingelheim Investigational Site 173

Sakai, Japan

Location

Boehringer Ingelheim Investigational Site 215

Sakaidechō, Japan

Location

Boehringer Ingelheim Investigational Site 118

Sakakimachi, Japan

Location

Boehringer Ingelheim Investigational Site 108

Sanjyo, Japan

Location

Boehringer Ingelheim Investigational Site 41

Sano, Japan

Location

Boehringer Ingelheim Investigational Site 1

Sapporo, Japan

Location

Boehringer Ingelheim Investigational Site 2

Sapporo, Japan

Location

Boehringer Ingelheim Investigational Site 3

Sapporo, Japan

Location

Boehringer Ingelheim Investigational Site 55

Sayama, Japan

Location

Boehringer Ingelheim Investigational Site 21

Sendai, Japan

Location

Boehringer Ingelheim Investigational Site 115

Shikamachichō-shimoutagaura, Japan

Location

Boehringer Ingelheim Investigational Site 210

Shimonoseki, Japan

Location

Boehringer Ingelheim Investigational Site 19

Shiogama, Japan

Location

Boehringer Ingelheim Investigational Site 32

Shirakawa, Japan

Location

Boehringer Ingelheim Investigational Site 132

Shizuoka, Japan

Location

Boehringer Ingelheim Investigational Site 133

Shizuoka, Japan

Location

Boehringer Ingelheim Investigational Site 50

Sōka, Japan

Location

Boehringer Ingelheim Investigational Site 174

Suita, Japan

Location

Boehringer Ingelheim Investigational Site 147

Suzuka, Japan

Location

Boehringer Ingelheim Investigational Site 69

Tachikawa, Japan

Location

Boehringer Ingelheim Investigational Site 70

Tachikawa, Japan

Location

Boehringer Ingelheim Investigational Site 71

Tachikawa, Japan

Location

Boehringer Ingelheim Investigational Site 20

Tagajyo, Japan

Location

Boehringer Ingelheim Investigational Site 44

Takasaki, Japan

Location

Boehringer Ingelheim Investigational Site 45

Takasaki, Japan

Location

Boehringer Ingelheim Investigational Site 150

Takashima, Japan

Location

Boehringer Ingelheim Investigational Site 84

Tama, Japan

Location

Boehringer Ingelheim Investigational Site 28

Tendō, Japan

Location

Boehringer Ingelheim Investigational Site 213

Tokushima, Japan

Location

Boehringer Ingelheim Investigational Site 72

Tokyo Adachi-ku, Japan

Location

Boehringer Ingelheim Investigational Site 73

Tokyo Adachi-ku, Japan

Location

Boehringer Ingelheim Investigational Site 74

Tokyo Bunkyo-ku, Japan

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Boehringer Ingelheim Investigational Site 75

Tokyo Bunkyo-ku, Japan

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Boehringer Ingelheim Investigational Site 79

Tokyo Chuo-ku, Japan

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Boehringer Ingelheim Investigational Site 77

Tokyo Edofawa-ku, Japan

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Boehringer Ingelheim Investigational Site 76

Tokyo Itabashi-ku, Japan

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Boehringer Ingelheim Investigational Site 89

Tokyo Katsushika-ku, Japan

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Boehringer Ingelheim Investigational Site 85

Tokyo Meguro-ku, Japan

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Boehringer Ingelheim Investigational Site 86

Tokyo Meguro-ku, Japan

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Boehringer Ingelheim Investigational Site 81

Tokyo Nerima-ku, Japan

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Boehringer Ingelheim Investigational Site 82

Tokyo Nerima-ku, Japan

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Boehringer Ingelheim Investigational Site 87

Tokyo Ota-ku, Japan

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Boehringer Ingelheim Investigational Site 67

Tokyo Shinjyuku-ku, Japan

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Boehringer Ingelheim Investigational Site 68

Tokyo Shinjyuku-ku, Japan

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Boehringer Ingelheim Investigational Site 78

Tokyo Sumida-ku, Japan

Location

Boehringer Ingelheim Investigational Site 88

Tokyo Sumida-ku, Japan

Location

Boehringer Ingelheim Investigational Site 80

Tokyo Toshima-ku, Japan

Location

Boehringer Ingelheim Investigational Site 214

Tonosho-cho, Japan

Location

Boehringer Ingelheim Investigational Site 221

Tosashimizu, Japan

Location

Boehringer Ingelheim Investigational Site 110

Toyama, Japan

Location

Boehringer Ingelheim Investigational Site 135

Toyohashi, Japan

Location

Boehringer Ingelheim Investigational Site 136

Toyohashi, Japan

Location

Boehringer Ingelheim Investigational Site 109

Tōkamachi, Japan

Location

Boehringer Ingelheim Investigational Site 146

Tsu, Japan

Location

Boehringer Ingelheim Investigational Site 36

Tsuchiura, Japan

Location

Boehringer Ingelheim Investigational Site 247

Tsunocho, Japan

Location

Boehringer Ingelheim Investigational Site 209

Ube, Japan

Location

Boehringer Ingelheim Investigational Site 123

Ueda, Japan

Location

Boehringer Ingelheim Investigational Site 42

Utsunomiya, Japan

Location

Boehringer Ingelheim Investigational Site 218

Uwajima, Japan

Location

Boehringer Ingelheim Investigational Site 251

Wadomari, Japan

Location

Boehringer Ingelheim Investigational Site 211

Yamaguchi, Japan

Location

Boehringer Ingelheim Investigational Site 190

Yamatokooriyama, Japan

Location

Boehringer Ingelheim Investigational Site 222

Yame, Japan

Location

Boehringer Ingelheim Investigational Site 93

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site 94

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site 95

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site 96

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site 97

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site 91

Yokosuka, Japan

Location

Boehringer Ingelheim Investigational Site 92

Yokosuka, Japan

Location

Boehringer Ingelheim Investigational Site 54

Yokoze-machi, Japan

Location

Boehringer Ingelheim Investigational Site 194

Yonago, Japan

Location

Boehringer Ingelheim Investigational Site 98

Zama, Japan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 13, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 18, 2014
• Results First Posted: August 18, 2014

Record last verified: 2014-07

Locations

JP (254)