26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
- Conditions
- Hypertension
- Registration Number
- NCT00624052
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10) during open-label treatment for at least six months.
An additional objective is to assess the efficacy and safety of concomitant administration of either T40/A10 or T80/A10 with any other therapies commonly used in the treatment of hypertension.
The primary endpoint is the proportion of patients achieving DBP control (defined as mean seated DBP \< 90 mmHg at trough i.e. approximately 24 hours after last dose of study treatment) at six months of treatment or at last trough observation during the treatment period (i.e. last trough observation carried forward).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 838
- diagnosis of essential hypertension
- pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
- development of any condition in the preceding trial that could be worsened by telmisartan 40mg/amlodipine 10mg (T40/A10) or telmisartan 80mg/amlodipine 10mg (T80/A10).
- discontinuation from the preceding trial.
- known or suspected secondary hypertension.
- mean seated systolic blood pressure (SBP) >= 180 mmHg and/or mean seated diastolic blood pressure (DBP) >= 120 mmHg at any visit.
- any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
- clinically relevant hyperkalaemia.
- uncorrected volume or sodium depletion.
- primary aldosteronism.
- hereditary fructose or lactose intolerance.
- symptomatic congestive heart failure.
- patients who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
- any new drug or alcohol dependency since signing consent of the preceding trial.
- concurrent participation in another clinical trial or any investigational therapy since completing the preceding trial.
- hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
- known allergic hypersensitivity to any component of the formulations under investigation. [Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).] non-compliance with study medication (defined as <80% or >120%) during the preceding trial.
- administration of ARBs or dihydropyridine CCBs (apart from trial medication). any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trough Seated Diastolic Blood Pressure (DBP) Control End of study (34 weeks or last value on treatment) The number of patients who reached the target DBP of \<90mmHg
- Secondary Outcome Measures
Name Time Method Trough Seated Systolic Blood Pressure (SBP) Control End of study (34 weeks or last value on treatment) The number of patients who reached the target SBP of \>=140mmHg
Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6
Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment) The difference between the last available troughs represents the additional reduction in DBP in this study
Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6
Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052 Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment) The difference between the last available troughs represents the additional reduction in SBP in this study
Trough Seated DBP Response End of study (34 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 Response End of study (34 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 BP Normality Classes End of study (34 weeks or last value on treatment) The number of patients who reach predefined BP categories
Time to First Additional Antihypertensive up to 34 weeks Time from first intake of medication to first intake of an antihypertensive other than the study drug
Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control up to 34 weeks The number of patients with DBP control (DBP\>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy up to 34 weeks Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy up to 34 weeks Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052
Trough DBP Control Pre- and Post- Uptitration up to 34 weeks The number of patients with DBP control (DBP\<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP\>90 or investigator opinion.
Trial Locations
- Locations (92)
1235.8.34005 Boehringer Ingelheim Investigational Site
🇪🇸Santa Coloma de Gramanet, Spain
1235.8.34004 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1235.8.34001 Boehringer Ingelheim Investigational Site
🇪🇸Jerez de la Frontera (Cádiz), Spain
1235.8.61004 Boehringer Ingelheim Investigational Site
🇦🇺Liverpool, New South Wales, Australia
1235.8.35902 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.8.34010 Boehringer Ingelheim Investigational Site
🇪🇸Badalona, Spain
1235.8.64002 Boehringer Ingelheim Investigational Site
🇳🇿Otahuhu, Auckland, New Zealand
1235.8.34002 Boehringer Ingelheim Investigational Site
🇪🇸Oviedo, Spain
1235.8.44003 Boehringer Ingelheim Investigational Site
🇬🇧Glasgow, United Kingdom
1235.8.34008 Boehringer Ingelheim Investigational Site
🇪🇸Badalona, Spain
1235.8.70008 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.8.44016 Boehringer Ingelheim Investigational Site
🇬🇧Blackpool, United Kingdom
1235.8.34011 Boehringer Ingelheim Investigational Site
🇪🇸Santa Coloma de Gramanet, Spain
1235.8.44011 Boehringer Ingelheim Investigational Site
🇬🇧Burbage, United Kingdom
1235.8.44007 Boehringer Ingelheim Investigational Site
🇬🇧Chestfield, Whitstable, United Kingdom
1235.8.44002 Boehringer Ingelheim Investigational Site
🇬🇧Edgbaston, Birmingham, United Kingdom
1235.8.44001 Boehringer Ingelheim Investigational Site
🇬🇧Fowey, United Kingdom
1235.8.44010 Boehringer Ingelheim Investigational Site
🇬🇧Bexhill on Sea, United Kingdom
1235.8.44009 Boehringer Ingelheim Investigational Site
🇬🇧Ely, United Kingdom
1235.8.44012 Boehringer Ingelheim Investigational Site
🇬🇧Penzance, United Kingdom
1235.8.44015 Boehringer Ingelheim Investigational Site
🇬🇧St. Austell, United Kingdom
1235.8.34006 Boehringer Ingelheim Investigational Site
🇪🇸L'Hospitalet de Llobregat (Barcelona), Spain
1235.8.34009 Boehringer Ingelheim Investigational Site
🇪🇸Barcelona, Spain
1235.8.34003 Boehringer Ingelheim Investigational Site
🇪🇸Madrid, Spain
1235.8.34012 Boehringer Ingelheim Investigational Site
🇪🇸Mataró, Spain
1235.8.43002 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1235.8.42001 Boehringer Ingelheim Investigational Site
🇨🇿Plzen, Czech Republic
1235.8.39002 Boehringer Ingelheim Investigational Site
🇮🇹Broni (pv), Italy
1235.8.44008 Boehringer Ingelheim Investigational Site
🇬🇧Blackpool, United Kingdom
1235.8.44005 Boehringer Ingelheim Investigational Site
🇬🇧Chorley, United Kingdom
1235.8.44013 Boehringer Ingelheim Investigational Site
🇬🇧Plymouth, United Kingdom
1235.8.44004 Boehringer Ingelheim Investigational Site
🇬🇧Reading, United Kingdom
1235.8.44006 Boehringer Ingelheim Investigational Site
🇬🇧Whitstable, United Kingdom
1235.8.43006 Boehringer Ingelheim Investigational Site
🇦🇹Hainburg a.d. Donau, Austria
1235.8.43001 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1235.8.42002 Boehringer Ingelheim Investigational Site
🇨🇿Benatky nad Jizerou, Czech Republic
1235.8.39001 Boehringer Ingelheim Investigational Site
🇮🇹Ferrara, Italy
1235.8.42103 Boehringer Ingelheim Investigational Site
🇸🇰Dolny Kubin, Slovakia
1235.8.42105 Boehringer Ingelheim Investigational Site
🇸🇰Presov, Slovakia
1235.8.38010 Boehringer Ingelheim Investigational Site
🇺🇦Dnepropetrovsk, Ukraine
1235.8.38011 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.8.38004 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.8.38013 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.8.61005 Boehringer Ingelheim Investigational Site
🇦🇺Elizabeth Vale, South Australia, Australia
1235.8.70009 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.8.35906 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.8.42005 Boehringer Ingelheim Investigational Site
🇨🇿Slany, Czech Republic
1235.8.35304 Boehringer Ingelheim Investigational Site
🇮🇪Birr, Ireland
1235.8.35305 Boehringer Ingelheim Investigational Site
🇮🇪Carrigtowhill, Ireland
1235.8.35303 Boehringer Ingelheim Investigational Site
🇮🇪Gorey, Co. Wexford, Ireland
1235.8.35306 Boehringer Ingelheim Investigational Site
🇮🇪Mallow, Ireland
1235.8.39006 Boehringer Ingelheim Investigational Site
🇮🇹Coppito (AQ), Italy
1235.8.64001 Boehringer Ingelheim Investigational Site
🇳🇿Tauranga, New Zealand
1235.8.61001 Boehringer Ingelheim Investigational Site
🇦🇺Milton, Queensland, Australia
1235.8.35904 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.8.35907 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.8.42006 Boehringer Ingelheim Investigational Site
🇨🇿Brno, Czech Republic
1235.8.42004 Boehringer Ingelheim Investigational Site
🇨🇿Pribram, Czech Republic
1235.8.42007 Boehringer Ingelheim Investigational Site
🇨🇿Strakonice, Czech Republic
1235.8.70010 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.8.42107 Boehringer Ingelheim Investigational Site
🇸🇰Vrable, Slovakia
1235.8.38012 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.8.38009 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1235.8.38002 Boehringer Ingelheim Investigational Site
🇺🇦Lvov, Ukraine
1235.8.61002 Boehringer Ingelheim Investigational Site
🇦🇺Kippa-Ring, Queensland, Australia
1235.8.70006 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.8.43003 Boehringer Ingelheim Investigational Site
🇦🇹Wien, Austria
1235.8.35912 Boehringer Ingelheim Investigational Site
🇧🇬Bourgas, Bulgaria
1235.8.35905 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.8.35910 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.8.42003 Boehringer Ingelheim Investigational Site
🇨🇿Praha 5, Czech Republic
1235.8.64003 Boehringer Ingelheim Investigational Site
🇳🇿Dunedin, New Zealand
1235.8.70011 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.8.42106 Boehringer Ingelheim Investigational Site
🇸🇰Kralovsky Chmlec, Slovakia
1235.8.42104 Boehringer Ingelheim Investigational Site
🇸🇰Liptovsky Mikulas, Slovakia
1235.8.38001 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.8.38003 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.8.38005 Boehringer Ingelheim Investigational Site
🇺🇦Odessa, Ukraine
1235.8.70007 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.8.43007 Boehringer Ingelheim Investigational Site
🇦🇹Eggenburg, Austria
1235.8.35903 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.8.35911 Boehringer Ingelheim Investigational Site
🇧🇬Sofia, Bulgaria
1235.8.35301 Boehringer Ingelheim Investigational Site
🇮🇪New Ross, Ireland
1235.8.70012 Boehringer Ingelheim Investigational Site
🇷🇺St. Petersburg, Russian Federation
1235.8.42102 Boehringer Ingelheim Investigational Site
🇸🇰Povazska Bystrica, Slovakia
1235.8.42101 Boehringer Ingelheim Investigational Site
🇸🇰Trencin, Slovakia
1235.8.38008 Boehringer Ingelheim Investigational Site
🇺🇦Kharkov, Ukraine
1235.8.38006 Boehringer Ingelheim Investigational Site
🇺🇦Kiev, Ukraine
1235.8.38007 Boehringer Ingelheim Investigational Site
🇺🇦Zaporozhye, Ukraine
1235.8.70004 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation
1235.8.61003 Boehringer Ingelheim Investigational Site
🇦🇺Gosford, New South Wales, Australia
1235.8.70005 Boehringer Ingelheim Investigational Site
🇷🇺Moscow, Russian Federation