Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension
- Conditions
- Hypertension
- Registration Number
- NCT00558428
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1098
- patients aged at least 18 years at the date of signing the consent form
- diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the study
- failure to respond adequately to six weeks treatment with amlodipine 5 mg monotherapy
- able to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigator's decision)
- willing and able to provide written informed consent (in accordance with Good Clinical Practice and local legislation).
- are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
- known or suspected secondary hypertension
- mean seated systolic blood pressure (SBP) over 200 mmHg and/or mean seated diastolic blood pressure (DBP) over 120 mmHg at Visit 1 or 2 or mean seated SBP over 180 mmHg and/or mean seated DBP over 120 mmHg at the end of the run-in period (Visit 3)
- any clinically significant hepatic impairment (e.g. clinically significant cholestasis, biliary obstructive disorder or hepatic insufficiency)
- severe renal impairment (e.g. serum creatinine >3.0 mg/dL or >265 mcmol/L, known creatinine clearance <30mL/min or clinical markers of severe renal impairment)
- bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
- clinically relevant hyperkalaemia
- uncorrected volume or sodium depletion.
- primary aldosteronism.
- hereditary fructose or lactose intolerance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) End of study (8 weeks or last value on treatment) Change from baseline to the end of study in trough DBP
Number of Patients With Oedema During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment) Patients from the treated set who experienced at least one case of general oedema.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) End of study (8 weeks or last value on treatment) Change from baseline to the end of study in trough SBP
Trough Seated Diastolic Blood Pressure Control End of study (8 weeks or last value on treatment) The number of patients who reach the target DBP of \<90mmHg
Trough Seated DBP Response End of study (8 weeks or last value on treatment) The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
Trough Seated SBP Control End of study (8 weeks or last value on treatment) The number of patients who reach the target SBP of \<140mmHg
Trough Seated SBP Response End of study (8 weeks or last value on treatment) The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
Trough Seated Blood Pressure (BP) Normality Classes End of study (8 weeks or last value on treatment) The number of patients who reach predefined BP categories:
* Optimal - SBP\<120 and DBP\<80 mmHg
* Normal - SBP\<130 and DBP\<85 mmHg
* High-normal - SBP\<140 DBP\<90 mmHg
* Stage 1 hypertension - SBP\<160 and DBP\<100
* Stage 2 hypertension SBP\>=160 and DBP\>=100 mmHg
Trial Locations
- Locations (129)
1235.5.31004 Boehringer Ingelheim Investigational Site
🇳🇱Hoogwoud, Netherlands
1235.5.31003 Boehringer Ingelheim Investigational Site
🇳🇱Musselkanaal, Netherlands
1235.5.31005 Boehringer Ingelheim Investigational Site
🇳🇱Roelofarendsveen, Netherlands
1235.5.82005 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.5.31008 Boehringer Ingelheim Investigational Site
🇳🇱Beerzerveld, Netherlands
1235.5.63006 Boehringer Ingelheim Investigational Site
🇵🇭Makati City, Philippines
1235.5.46005 Boehringer Ingelheim Investigational Site
🇸🇪Luleå, Sweden
1235.5.27008 Boehringer Ingelheim Investigational Site
🇿🇦Johannesburg, South Africa
1235.5.82008 Boehringer Ingelheim Investigational Site
🇰🇷Gwangju, Korea, Republic of
1235.5.3307D Boehringer Ingelheim Investigational Site
🇫🇷Le Mesnil en Vallée, France
1235.5.3301G Boehringer Ingelheim Investigational Site
🇫🇷La Montagne, France
1235.5.3302A Boehringer Ingelheim Investigational Site
🇫🇷Nevers, France
1235.5.3301J Boehringer Ingelheim Investigational Site
🇫🇷La Chapelle sur Erdre, France
1235.5.3307F Boehringer Ingelheim Investigational Site
🇫🇷Parcay les Pins, France
1235.5.3301N Boehringer Ingelheim Investigational Site
🇫🇷Sautron, France
1235.5.3310A Boehringer Ingelheim Investigational Site
🇫🇷Jarny, France
1235.5.3301F Boehringer Ingelheim Investigational Site
🇫🇷St Aubin les Châteaux, France
1235.5.3307A Boehringer Ingelheim Investigational Site
🇫🇷Murs-Erigne, France
1235.5.3307C Boehringer Ingelheim Investigational Site
🇫🇷Saint Pierre Montlimard, France
1235.5.3301M Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
1235.5.3304C Boehringer Ingelheim Investigational Site
🇫🇷Tinténiac, France
1235.5.82003 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.5.45001 Boehringer Ingelheim Investigational Site
🇩🇰Rødovre, Denmark
1235.5.45006 Boehringer Ingelheim Investigational Site
🇩🇰Rødovre, Denmark
1235.5.46001 Boehringer Ingelheim Investigational Site
🇸🇪Stockholm, Sweden
1235.5.63009 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
1235.5.20013 Boehringer Ingelheim Investigational Site
🇨🇦Corunna, Ontario, Canada
1235.5.20009 Boehringer Ingelheim Investigational Site
🇨🇦Ottawa, Ontario, Canada
1235.5.3301E Boehringer Ingelheim Investigational Site
🇫🇷Le Temple de Bretagne, France
1235.5.3307G Boehringer Ingelheim Investigational Site
🇫🇷Loudun, France
1235.5.3306B Boehringer Ingelheim Investigational Site
🇫🇷Segre, France
1235.5.31006 Boehringer Ingelheim Investigational Site
🇳🇱Bennebroek, Netherlands
1235.5.31007 Boehringer Ingelheim Investigational Site
🇳🇱Nijverdal, Netherlands
1235.5.47002 Boehringer Ingelheim Investigational Site
🇳🇴Bergen, Norway
1235.5.31001 Boehringer Ingelheim Investigational Site
🇳🇱Oude Pekela, Netherlands
1235.5.31010 Boehringer Ingelheim Investigational Site
🇳🇱Voerendaal, Netherlands
1235.5.47004 Boehringer Ingelheim Investigational Site
🇳🇴Oslo, Norway
1235.5.47001 Boehringer Ingelheim Investigational Site
🇳🇴Ålesund, Norway
1235.5.63001 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
1235.5.63002 Boehringer Ingelheim Investigational Site
🇵🇭Manila, Philippines
1235.5.63005 Boehringer Ingelheim Investigational Site
🇵🇭Pasig City, Philippines
1235.5.27009 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
1235.5.63003 Boehringer Ingelheim Investigational Site
🇵🇭Quezon City, Philippines
1235.5.63007 Boehringer Ingelheim Investigational Site
🇵🇭Quezon City, Philippines
1235.5.27006 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
1235.5.27010 Boehringer Ingelheim Investigational Site
🇿🇦Cape Town, South Africa
1235.5.27004 Boehringer Ingelheim Investigational Site
🇿🇦Durban, South Africa
1235.5.27001 Boehringer Ingelheim Investigational Site
🇿🇦Krugersdorp, South Africa
1235.5.27005 Boehringer Ingelheim Investigational Site
🇿🇦Lenasia, South Africa
1235.5.46002 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1235.5.27002 Boehringer Ingelheim Investigational Site
🇿🇦Pretoria, South Africa
1235.5.46003 Boehringer Ingelheim Investigational Site
🇸🇪Göteborg, Sweden
1235.5.46004 Boehringer Ingelheim Investigational Site
🇸🇪Rättvik, Sweden
1235.5.88603 Boehringer Ingelheim Investigational Site
🇨🇳Taichung, Taiwan
1235.5.88605 Boehringer Ingelheim Investigational Site
🇨🇳Changhua, Taiwan
1235.5.88608 Boehringer Ingelheim Investigational Site
🇨🇳Hualien City, Taiwan
1235.5.88601 Boehringer Ingelheim Investigational Site
🇨🇳Kaohsiung, Taiwan
1235.5.32010 Boehringer Ingelheim Investigational Site
🇧🇪Gozée, Belgium
1235.5.32008 Boehringer Ingelheim Investigational Site
🇧🇪Linkebeek, Belgium
1235.5.32007 Boehringer Ingelheim Investigational Site
🇧🇪Natoye, Belgium
1235.5.32009 Boehringer Ingelheim Investigational Site
🇧🇪Tavier, Belgium
1235.5.20005 Boehringer Ingelheim Investigational Site
🇨🇦Mount Pearl, Newfoundland and Labrador, Canada
1235.5.20007 Boehringer Ingelheim Investigational Site
🇨🇦Bay Roberts, Newfoundland and Labrador, Canada
1235.5.20008 Boehringer Ingelheim Investigational Site
🇨🇦St. John's, Newfoundland and Labrador, Canada
1235.5.45007 Boehringer Ingelheim Investigational Site
🇩🇰Vildbjerg, Denmark
1235.5.20014 Boehringer Ingelheim Investigational Site
🇨🇦Etobicoke, Ontario, Canada
1235.5.20012 Boehringer Ingelheim Investigational Site
🇨🇦London, Ontario, Canada
1235.5.20006 Boehringer Ingelheim Investigational Site
🇨🇦Sarnia, Ontario, Canada
1235.5.45005 Boehringer Ingelheim Investigational Site
🇩🇰Haderslev, Denmark
1235.5.20003 Boehringer Ingelheim Investigational Site
🇨🇦Sainte-Foy, Quebec, Canada
1235.5.45002 Boehringer Ingelheim Investigational Site
🇩🇰Birkerød, Denmark
1235.5.45008 Boehringer Ingelheim Investigational Site
🇩🇰Herning, Denmark
1235.5.45009 Boehringer Ingelheim Investigational Site
🇩🇰Hinnerup, Denmark
1235.5.45003 Boehringer Ingelheim Investigational Site
🇩🇰Vaerløse, Denmark
1235.5.35001 Boehringer Ingelheim Investigational Site
🇫🇮Turku, Finland
1235.5.3309B Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
1235.5.3306C Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
1235.5.35002 Boehringer Ingelheim Investigational Site
🇫🇮Turku, Finland
1235.5.3301H Boehringer Ingelheim Investigational Site
🇫🇷Aigrefeuille S/Maine, France
1235.5.3309C Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
1235.5.3309A Boehringer Ingelheim Investigational Site
🇫🇷Beaucouze, France
1235.5.3309D Boehringer Ingelheim Investigational Site
🇫🇷Avrille, France
1235.5.3305A Boehringer Ingelheim Investigational Site
🇫🇷Bourg des cptes, France
1235.5.3306D Boehringer Ingelheim Investigational Site
🇫🇷Briollay, France
1235.5.3308F Boehringer Ingelheim Investigational Site
🇫🇷Cholet, France
1235.5.3308D Boehringer Ingelheim Investigational Site
🇫🇷Cholet, France
1235.5.3308C Boehringer Ingelheim Investigational Site
🇫🇷Cholet, France
1235.5.3303C Boehringer Ingelheim Investigational Site
🇫🇷Grandchamps, France
1235.5.3302C Boehringer Ingelheim Investigational Site
🇫🇷Garchizy, France
1235.5.3302D Boehringer Ingelheim Investigational Site
🇫🇷Guerigny, France
1235.5.3301L Boehringer Ingelheim Investigational Site
🇫🇷La Chapelle /s Erdre, France
1235.5.3303B Boehringer Ingelheim Investigational Site
🇫🇷Le Bono, France
1235.5.3309F Boehringer Ingelheim Investigational Site
🇫🇷Les Ponts de CE, France
1235.5.3305B Boehringer Ingelheim Investigational Site
🇫🇷Louvigné le Bais, France
1235.5.3306A Boehringer Ingelheim Investigational Site
🇫🇷Murs Erigne, France
1235.5.3307E Boehringer Ingelheim Investigational Site
🇫🇷Mouliherne, France
1235.5.3301A Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
1235.5.3301D Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
1235.5.3301B Boehringer Ingelheim Investigational Site
🇫🇷Nantes, France
1235.5.3301I Boehringer Ingelheim Investigational Site
🇫🇷Nort sur Erdre, France
1235.5.3302F Boehringer Ingelheim Investigational Site
🇫🇷Nevers, France
1235.5.3304B Boehringer Ingelheim Investigational Site
🇫🇷St Ouen La Rouerie, France
1235.5.3306F Boehringer Ingelheim Investigational Site
🇫🇷St Georges de Montaigu, France
1235.5.3306E Boehringer Ingelheim Investigational Site
🇫🇷Thouars, France
1235.5.3303A Boehringer Ingelheim Investigational Site
🇫🇷Vannes, France
1235.5.82001 Boehringer Ingelheim Investigational Site
🇰🇷Daegu, Korea, Republic of
1235.5.82006 Boehringer Ingelheim Investigational Site
🇰🇷Daejon, Korea, Republic of
1235.5.3308A Boehringer Ingelheim Investigational Site
🇫🇷Vihiers, France
1235.5.82004 Boehringer Ingelheim Investigational Site
🇰🇷Gangwon-Do, Korea, Republic of
1235.5.82002 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
1235.5.3308E Boehringer Ingelheim Investigational Site
🇫🇷La Jubaudière, France
1235.5.3304A Boehringer Ingelheim Investigational Site
🇫🇷La Fresnais, France
1235.5.20010 Boehringer Ingelheim Investigational Site
🇨🇦Hamilton, Ontario, Canada
1235.5.27003 Boehringer Ingelheim Investigational Site
🇿🇦Boksburg, South Africa
1235.5.3309E Boehringer Ingelheim Investigational Site
🇫🇷Angers, France
1235.5.3308B Boehringer Ingelheim Investigational Site
🇫🇷Cholet, France
1235.5.3301C Boehringer Ingelheim Investigational Site
🇫🇷Orvault, France
1235.5.82007 Boehringer Ingelheim Investigational Site
🇰🇷Busan, Korea, Republic of
1235.5.63008 Boehringer Ingelheim Investigational Site
🇵🇭Pasay City, Philippines
1235.5.35004 Boehringer Ingelheim Investigational Site
🇫🇮Joensuu, Finland
1235.5.47003 Boehringer Ingelheim Investigational Site
🇳🇴Hamar, Norway
1235.5.32004 Boehringer Ingelheim Investigational Site
🇧🇪Aywaille, Belgium
1235.5.32001 Boehringer Ingelheim Investigational Site
🇧🇪Bruxelles, Belgium
1235.5.32003 Boehringer Ingelheim Investigational Site
🇧🇪Mol, Belgium
1235.5.32005 Boehringer Ingelheim Investigational Site
🇧🇪Turnhout, Belgium
1235.5.32002 Boehringer Ingelheim Investigational Site
🇧🇪Tienen-Kumtich, Belgium
1235.5.35003 Boehringer Ingelheim Investigational Site
🇫🇮Joensuu, Finland
1235.5.20001 Boehringer Ingelheim Investigational Site
🇨🇦Coquitlam, British Columbia, Canada
1235.5.20011 Boehringer Ingelheim Investigational Site
🇨🇦Vancouver, British Columbia, Canada