HypertensionNCT00909038
Telmisartan 80mg+Hydrochlorothiazide (HCTZ) 25 mg in Hypertension: an Observational Study
An observational study of Hypertension, run by Boehringer Ingelheim at 915 sites in France.
Trial summary
It is a national, retrospective , observational study in hypertensive patients treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg. The primary objective is to assess the control rate (systolic and diastolic blood pressure). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 2,411 participants
- Where
- 915 sitesFrance
- Study dates
- May 2009to Nov 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3440
Who may be able to join
- Hypertensives
- Treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg
Who cannot join
- Treated with the combination less than 8 weeks
Trial locations and contacts
915 sites in 1 country.
300 sites in 1 country
France300 sites
Boehringer Ingelheim Investigator site 1
Ablon-sur-Seine
Boehringer Ingelheim Investigator site 2
Achenheim
Boehringer Ingelheim Investigator site 3
Afa
Boehringer Ingelheim Investigator site 4
Aiguillon
Boehringer Ingelheim Investigator site 5
Aire-sur-l'Adour
Boehringer Ingelheim Investigator site 6
Aix-en-Othe
Boehringer Ingelheim Investigator site 7
Aix-en-Provence
Boehringer Ingelheim Investigator site 8
Aix-en-Provence
Boehringer Ingelheim Investigator site 9
Aix-les-Bains
Boehringer Ingelheim Investigator site 10
Ajaccio
Boehringer Ingelheim Investigator site 11
Ajaccio
Boehringer Ingelheim Investigator site 12
Amagne
Boehringer Ingelheim Investigator site 13
Amiens
Boehringer Ingelheim Investigator site 14
Amiens
Boehringer Ingelheim Investigator site 15
Andard
Boehringer Ingelheim Investigator site 16
Angers
Boehringer Ingelheim Investigator site 17
Angoulême
Boehringer Ingelheim Investigator site 18
Angoulême
Boehringer Ingelheim Investigator site 19
Angoulême
Boehringer Ingelheim Investigator site 20
Annecy
Boehringer Ingelheim Investigator site 21
Annecy
Boehringer Ingelheim Investigator site 22
Annemasse
Boehringer Ingelheim Investigator site 23
Annonay
Boehringer Ingelheim Investigator site 24
Annonay
Boehringer Ingelheim Investigator site 25
Antibes
Boehringer Ingelheim Investigator site 26
Antony
Boehringer Ingelheim Investigator site 27
Anvin
Boehringer Ingelheim Investigator site 28
Anzin
Boehringer Ingelheim Investigator site 29
Appoigny
Boehringer Ingelheim Investigator site 30
Ardentes
Boehringer Ingelheim Investigator site 31
Argenteuil
Boehringer Ingelheim Investigator site 32
Arles
Boehringer Ingelheim Investigator site 33
Arques-la-Bataille
Boehringer Ingelheim Investigator site 34
Arradon
Boehringer Ingelheim Investigator site 35
Ars
Boehringer Ingelheim Investigator site 36
Arsac
Boehringer Ingelheim Investigator site 37
Artigues-près-Bordeaux
Boehringer Ingelheim Investigator site 38
Asnières-sur-Seine
Boehringer Ingelheim Investigator site 39
Asson
Boehringer Ingelheim Investigator site 40
Aubervilliers
Boehringer Ingelheim Investigator site 41
Auch
Boehringer Ingelheim Investigator site 42
Augny
Boehringer Ingelheim Investigator site 43
Aulnay-sous-Bois
Boehringer Ingelheim Investigator site 44
Aulnay-sous-Bois
Boehringer Ingelheim Investigator site 45
Aumetz
Boehringer Ingelheim Investigator site 46
Auxerre
Boehringer Ingelheim Investigator site 47
Auzon
Boehringer Ingelheim Investigator site 48
Avallon
Boehringer Ingelheim Investigator site 49
Bagneux
Boehringer Ingelheim Investigator site 50
Bagnols-sur-Cèze
Boehringer Ingelheim Investigator site 51
Baillet-en-France
Boehringer Ingelheim Investigator site 52
Bailleul
Boehringer Ingelheim Investigator site 53
Barbezieux-Saint-Hilaire
Boehringer Ingelheim Investigator site 54
Barbezieux-Saint-Hilaire
Boehringer Ingelheim Investigator site 55
Bassillac
Boehringer Ingelheim Investigator site 56
Bassussarry
Boehringer Ingelheim Investigator site 57
Bauvin
Boehringer Ingelheim Investigator site 58
Bayeux
Boehringer Ingelheim Investigator site 59
Beaumont-sur-Lèze
Boehringer Ingelheim Investigator site 60
Beauvais
Boehringer Ingelheim Investigator site 61
Bélâbre
Boehringer Ingelheim Investigator site 62
Belley
Boehringer Ingelheim Investigator site 63
Benfeld
Boehringer Ingelheim Investigator site 64
Bergerac
Boehringer Ingelheim Investigator site 65
Bergues
Boehringer Ingelheim Investigator site 66
Bersée
Boehringer Ingelheim Investigator site 67
Béthisy-Saint-Pierre
Boehringer Ingelheim Investigator site 68
Béziers
Boehringer Ingelheim Investigator site 69
Biarritz
Boehringer Ingelheim Investigator site 70
Biganos
Boehringer Ingelheim Investigator site 71
Biganos
Boehringer Ingelheim Investigator site 72
Biganos
Boehringer Ingelheim Investigator site 73
Billère
Boehringer Ingelheim Investigator site 74
Billère
Boehringer Ingelheim Investigator site 75
Blangy-sur-Bresle
Boehringer Ingelheim Investigator site 76
Blanquefort
Boehringer Ingelheim Investigator site 77
Blaye
Boehringer Ingelheim Investigator site 78
Bleriot
Boehringer Ingelheim Investigator site 79
Blois
Boehringer Ingelheim Investigator site 80
Blotzheim
Boehringer Ingelheim Investigator site 81
Bohain-en-Vermandois
Boehringer Ingelheim Investigator site 82
Bois-Colombes
Boehringer Ingelheim Investigator site 83
Bois-Colombes
Boehringer Ingelheim Investigator site 84
Boiscommun
Boehringer Ingelheim Investigator site 85
Bondoufle
Boehringer Ingelheim Investigator site 86
Bondoufle
Boehringer Ingelheim Investigator site 87
Bondues
Boehringer Ingelheim Investigator site 88
Boos
Boehringer Ingelheim Investigator site 89
Boos
Boehringer Ingelheim Investigator site 90
Bordeaux
Boehringer Ingelheim Investigator site 91
Bordeaux
Boehringer Ingelheim Investigator site 92
Bordeaux
Boehringer Ingelheim Investigator site 93
Bordeaux
Boehringer Ingelheim Investigator site 94
Bouilly
Boehringer Ingelheim Investigator site 95
Boulogne-Billancourt
Boehringer Ingelheim Investigator site 96
Bourg-la-Reine
Boehringer Ingelheim Investigator site 97
Bourron-Marlotte
Boehringer Ingelheim Investigator site 98
Bourth
Boehringer Ingelheim Investigator site 99
Braine
Boehringer Ingelheim Investigator site 100
Brest
Boehringer Ingelheim Investigator site 101
Brest
Boehringer Ingelheim Investigator site 102
Brest
Boehringer Ingelheim Investigator site 103
Brest
Boehringer Ingelheim Investigator site 104
Brest
Boehringer Ingelheim Investigator site 105
Bretenoux
Boehringer Ingelheim Investigator site 107
Breteuil
Boehringer Ingelheim Investigator site 106
Breteuil
Boehringer Ingelheim Investigator site 108
Bretignolles-sur-Mer
Boehringer Ingelheim Investigator site 109
Bretteville-l'Orgueilleuse
Boehringer Ingelheim Investigator site 110
Brie
Boehringer Ingelheim Investigator site 111
Brienne-le-Château
Boehringer Ingelheim Investigator site 112
Briouze
Boehringer Ingelheim Investigator site 113
Bron
Boehringer Ingelheim Investigator site 114
Bruère-Allichamps
Boehringer Ingelheim Investigator site 115
Bruges
Boehringer Ingelheim Investigator site 116
Brunehamel
Boehringer Ingelheim Investigator site 117
Buchy
Boehringer Ingelheim Investigator site 118
Bulgnéville
Boehringer Ingelheim Investigator site 119
Bulgnéville
Boehringer Ingelheim Investigator site 120
Cabanac-et-Villagrains
Boehringer Ingelheim Investigator site 121
Cabannes
Boehringer Ingelheim Investigator site 122
Cabestany
Boehringer Ingelheim Investigator site 123
Caen
Boehringer Ingelheim Investigator site 124
Cagnes-sur-Mer
Boehringer Ingelheim Investigator site 125
Cagnes-sur-Mer
Boehringer Ingelheim Investigator site 126
Cagnes-sur-Mer
Boehringer Ingelheim Investigator site 127
Callac de Bretagne
Boehringer Ingelheim Investigator site 128
Callac de Bretagne
Boehringer Ingelheim Investigator site 129
Cancon
Boehringer Ingelheim Investigator site 130
Canéjan
Boehringer Ingelheim Investigator site 131
Cannes
Boehringer Ingelheim Investigator site 132
Cannes
Boehringer Ingelheim Investigator site 133
Cannes
Boehringer Ingelheim Investigator site 134
Cany-Barville
Boehringer Ingelheim Investigator site 135
Capdenac-Gare
Boehringer Ingelheim Investigator site 136
Capdenac-Gare
Boehringer Ingelheim Investigator site 137
Carbon-Blanc
Boehringer Ingelheim Investigator site 138
Carcassonne
Boehringer Ingelheim Investigator site 139
Carcassonne
Boehringer Ingelheim Investigator site 140
Carcassonne
Boehringer Ingelheim Investigator site 141
Carhaix-Plouguer
Boehringer Ingelheim Investigator site 142
Carpentras
Boehringer Ingelheim Investigator site 143
Carvin
Boehringer Ingelheim Investigator site 144
Cassis
Boehringer Ingelheim Investigator site 145
Castanet-Tolosan
Boehringer Ingelheim Investigator site 146
Castelnau-le-Lez
Boehringer Ingelheim Investigator site 147
Castelsarrasin
Boehringer Ingelheim Investigator site 148
Castelsarrasin
Boehringer Ingelheim Investigator site 149
Castets
Boehringer Ingelheim Investigator site 150
Castets-en-Dorthe
Boehringer Ingelheim Investigator site 151
Cavalaire-sur-Mer
Boehringer Ingelheim Investigator site 152
Cepoy
Boehringer Ingelheim Investigator site 153
Cergy
Boehringer Ingelheim Investigator site 154
Cérilly
Boehringer Ingelheim Investigator site 155
Cernay
Boehringer Ingelheim Investigator site 156
Châbons
Boehringer Ingelheim Investigator site 157
Chalais
Boehringer Ingelheim Investigator site 158
Chambray-lès-Tours
Boehringer Ingelheim Investigator site 159
Champs-sur-Marne
Boehringer Ingelheim Investigator site 160
Chantilly
Boehringer Ingelheim Investigator site 161
Chaource
Boehringer Ingelheim Investigator site 162
Charleville-Mézières
Boehringer Ingelheim Investigator site 163
Charleville-Mézières
Boehringer Ingelheim Investigator site 164
Chassieu
Boehringer Ingelheim Investigator site 165
Château-Chinon(Ville)
Boehringer Ingelheim Investigator site 166
Château-d'Olonne
Boehringer Ingelheim Investigator site 167
Château-Renault
Boehringer Ingelheim Investigator site 168
Château-Thébaud
Boehringer Ingelheim Investigator site 169
Châteaubernard
Boehringer Ingelheim Investigator site 170
Châteaubriant
Boehringer Ingelheim Investigator site 171
Chateauneuf Ille Vilaine
Boehringer Ingelheim Investigator site 172
Châteauroux
Boehringer Ingelheim Investigator site 173
Châtenay-Malabry
Boehringer Ingelheim Investigator site 174
Châtillon-Coligny
Boehringer Ingelheim Investigator site 175
Châtillon-sur-Seine
Boehringer Ingelheim Investigator site 176
Chaumont
Boehringer Ingelheim Investigator site 177
Chauvigny
Boehringer Ingelheim Investigator site 178
Chauvigny
Boehringer Ingelheim Investigator site 179
Chauvigny
Boehringer Ingelheim Investigator site 180
Chelles
Boehringer Ingelheim Investigator site 181
Cherves-Richemont
Boehringer Ingelheim Investigator site 182
Chinon
Boehringer Ingelheim Investigator site 183
Claira
Boehringer Ingelheim Investigator site 184
Clamart
Boehringer Ingelheim Investigator site 185
Claye-Souilly
Boehringer Ingelheim Investigator site 186
Clermont-Ferrand
Boehringer Ingelheim Investigator site 187
Clichy
Boehringer Ingelheim Investigator site 188
Clisson
Boehringer Ingelheim Investigator site 189
Cognac
Boehringer Ingelheim Investigator site 190
Colombes
Boehringer Ingelheim Investigator site 191
Colombes
Boehringer Ingelheim Investigator site 192
Colombes
Boehringer Ingelheim Investigator site 193
Combles
Boehringer Ingelheim Investigator site 194
Comines
Boehringer Ingelheim Investigator site 195
Condé-sur-l'Escaut
Boehringer Ingelheim Investigator site 196
Condom
Boehringer Ingelheim Investigator site 197
Conflans Ste Honorine
Boehringer Ingelheim Investigator site 198
Conflans Ste Honorine
Boehringer Ingelheim Investigator site 199
Corbehem
Boehringer Ingelheim Investigator site 200
Cornebarrieu
Boehringer Ingelheim Investigator site 201
Coubron
Boehringer Ingelheim Investigator site 202
Courbevoie
Boehringer Ingelheim Investigator site 203
Courbevoie
Boehringer Ingelheim Investigator site 204
Courseulles-sur-Mer
Boehringer Ingelheim Investigator site 205
Coutances
Boehringer Ingelheim Investigator site 206
Creil
Boehringer Ingelheim Investigator site 207
Creully
Boehringer Ingelheim Investigator site 208
Creutzwald
Boehringer Ingelheim Investigator site 209
Croix
Boehringer Ingelheim Investigator site 210
Croix
Boehringer Ingelheim Investigator site 211
Cros-de-Cagnes
Boehringer Ingelheim Investigator site 212
Crosne
Boehringer Ingelheim Investigator site 213
Cugnaux
Boehringer Ingelheim Investigator site 214
Culoz
Boehringer Ingelheim Investigator site 215
Damprichard
Boehringer Ingelheim Investigator site 216
Damvillers
Boehringer Ingelheim Investigator site 217
Danjoutin
Boehringer Ingelheim Investigator site 218
Dax
Boehringer Ingelheim Investigator site 219
Décines-Charpieu
Boehringer Ingelheim Investigator site 220
Diemeringen
Boehringer Ingelheim Investigator site 221
Digne-les-Bains
Boehringer Ingelheim Investigator site 222
Dijon
Boehringer Ingelheim Investigator site 223
Dijon
Boehringer Ingelheim Investigator site 224
Dijon
Boehringer Ingelheim Investigator site 225
Dinan
Boehringer Ingelheim Investigator site 226
Dinard
Boehringer Ingelheim Investigator site 227
Dole
Boehringer Ingelheim Investigator site 228
Domont
Boehringer Ingelheim Investigator site 229
Douai
Boehringer Ingelheim Investigator site 230
Dourdan
Boehringer Ingelheim Investigator site 231
Douvaine
Boehringer Ingelheim Investigator site 232
Douvres-la-Délivrande
Boehringer Ingelheim Investigator site 233
Drancy
Boehringer Ingelheim Investigator site 234
Drancy
Boehringer Ingelheim Investigator site 235
Drap
Boehringer Ingelheim Investigator site 236
Drulingen
Boehringer Ingelheim Investigator site 237
Échirolles
Boehringer Ingelheim Investigator site 238
Échirolles
Boehringer Ingelheim Investigator site 239
Elliant
Boehringer Ingelheim Investigator site 240
Enghien-les-Bains
Boehringer Ingelheim Investigator site 241
Enghien-les-Bains
Boehringer Ingelheim Investigator site 242
Épernay
Boehringer Ingelheim Investigator site 243
Épernon
Boehringer Ingelheim Investigator site 244
Épierre
Boehringer Ingelheim Investigator site 245
Épinal
Boehringer Ingelheim Investigator site 246
Épinay-sur-Orge
Boehringer Ingelheim Investigator site 247
Ermont
Boehringer Ingelheim Investigator site 248
Esquerdes
Boehringer Ingelheim Investigator site 249
Estrablin
Boehringer Ingelheim Investigator site 250
Estrées-Saint-Denis
Boehringer Ingelheim Investigator site 251
Étampes
Boehringer Ingelheim Investigator site 252
Eu
Boehringer Ingelheim Investigator site 253
Eygalières
Boehringer Ingelheim Investigator site 254
Eyragues
Boehringer Ingelheim Investigator site 255
Fabrezan
Boehringer Ingelheim Investigator site 256
Faches-Thumesnil
Boehringer Ingelheim Investigator site 257
Famars
Boehringer Ingelheim Investigator site 258
Fauquembergues
Boehringer Ingelheim Investigator site 259
Fécamp
Boehringer Ingelheim Investigator site 260
Félines
Boehringer Ingelheim Investigator site 261
Figeac
Boehringer Ingelheim Investigator site 262
Firmi
Boehringer Ingelheim Investigator site 263
Firminy
Boehringer Ingelheim Investigator site 264
Fitilieu
Boehringer Ingelheim Investigator site 265
Flayosc
Boehringer Ingelheim Investigator site 266
Fleurance
Boehringer Ingelheim Investigator site 267
Fleury-sur-Orne
Boehringer Ingelheim Investigator site 268
Flize
Boehringer Ingelheim Investigator site 269
Florensac
Boehringer Ingelheim Investigator site 270
Folembray
Boehringer Ingelheim Investigator site 271
Fontaine-lès-Dijon
Boehringer Ingelheim Investigator site 272
Fontaine-lès-Dijon
Boehringer Ingelheim Investigator site 273
Fontenay-le-Comte
Boehringer Ingelheim Investigator site 274
Fontenay-sous-Bois
Boehringer Ingelheim Investigator site 275
Fos-sur-Mer
Boehringer Ingelheim Investigator site 276
Fosses
Boehringer Ingelheim Investigator site 277
Fougères
Boehringer Ingelheim Investigator site 278
Fougères
Boehringer Ingelheim Investigator site 279
Franconville
Boehringer Ingelheim Investigator site 280
Frasne
Boehringer Ingelheim Investigator site 281
Frencq
Boehringer Ingelheim Investigator site 282
Fresnes-sur-Escaut
Boehringer Ingelheim Investigator site 283
Froideconche
Boehringer Ingelheim Investigator site 284
Fruges
Boehringer Ingelheim Investigator site 285
Gagny
Boehringer Ingelheim Investigator site 286
Gallardon
Boehringer Ingelheim Investigator site 287
Garchizy
Boehringer Ingelheim Investigator site 288
Gâvres
Boehringer Ingelheim Investigator site 289
Gennes
Boehringer Ingelheim Investigator site 290
Gentilly
Boehringer Ingelheim Investigator site 291
Giraumont
Boehringer Ingelheim Investigator site 292
Gironcourt-sur-Vraine
Boehringer Ingelheim Investigator site 293
Golbey
Boehringer Ingelheim Investigator site 294
Gondrecourt-le-Château
Boehringer Ingelheim Investigator site 295
Gontaud-de-Nogaret
Boehringer Ingelheim Investigator site 296
Goudelin
Boehringer Ingelheim Investigator site 297
Gouville-sur-Mer
Boehringer Ingelheim Investigator site 298
Grambois
Boehringer Ingelheim Investigator site 299
Gray
Boehringer Ingelheim Investigator site 300
Grenoble
About this study
Official title: A Descriptive Pharmaco-epidemiological Study of a Hypertensive Patient Population Treated With a Fixed-dose Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg and of Conditions for the Management of Arterial Hypertension
It is a national, retrospective , observational study in hypertensive patients treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg. The primary objective is to assess the control rate (systolic and diastolic blood pressure). Key secondary objectives are to assess the blood pressure reduction after at least 8 weeks of treatment, describe the population treated with this new fixed dose combination
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of BP Control in Hypertensive Patients
Percentage of controlled Patients at the Study End.
Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines.
Measured: Baseline to a minimum of 8 weeks of treatment
Secondary outcomes (5)
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population
Mean SBP measured at the Study End
Measured: baseline to a minimum of 8 weeks of treatment
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population
Mean DBP measured at the Study End
Measured: baseline to a minimum of 8 weeks of treatment
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk
Mean SBP measured at the Study End
Measured: baseline to a minimum of 8 weeks of treatment
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk
Mean DBP measured at the Study End
Measured: baseline to a minimum of 8 weeks of treatment
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007
The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.
Measured: Baseline to a minimum of 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909038
- Sponsor's protocol ID
- 502.574
- Status last verified
- May 2014
- First submitted
- 26 May 2009
- Last updated
- 5 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Pharmaco-epidemiological Study of a Hypertensive Patient Population Treated With a Fixed-dose Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg and of Conditions for the Management of Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00909038
- Acronym / sponsor ID
- 502.574
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,411 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Posted 14 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is a national, retrospective , observational study in hypertensive patients treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg. The primary objective is to assess the control rate (systolic and diastolic blood pressure). Key secondary objectives are to assess the blood pressure reduction after at least 8 weeks of treatment, describe the population treated with this new fixed dose combination
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3440
Key inclusion criteria (2 listed)
- Hypertensives
- Treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg
Key exclusion criteria (1 listed)
- Treated with the combination less than 8 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of BP Control in Hypertensive Patients
Time frame: Baseline to a minimum of 8 weeks of treatment
Percentage of controlled Patients at the Study End. Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines.
5 secondary outcomes
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population
Time frame: baseline to a minimum of 8 weeks of treatment
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population
Time frame: baseline to a minimum of 8 weeks of treatment
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk
Time frame: baseline to a minimum of 8 weeks of treatment
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk
Time frame: baseline to a minimum of 8 weeks of treatment
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007
Time frame: Baseline to a minimum of 8 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Chronic Kidney Disease, Hypertension (HTN)
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Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
915 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Boehringer Ingelheim at 915 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 915 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of BP Control in Hypertensive Patients (time frame: Baseline to a minimum of 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.