Hypertension Clinical Trial
Official title:
An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy
The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.
| Status | Completed |
| Enrollment | 947 |
| Est. completion date | |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg if treatment-naïve). - failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP >= 90 mmHg.) - able to stop any current antihypertensive therapy without unacceptable risk to the patient. - willing and able to provide written informed consent. Exclusion Criteria: - pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential). - known or suspected secondary hypertension. - mean seated systolic blood pressure (SBP) >=200 mmHg and/or mean seated DBP >= 120 mmHg during run-in treatment or mean seated SBP >= 180 mmHg and/or mean seated DBP >= 120 mmHg at the randomisation visit or at any time during randomised treatment. - 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 ACE inhibitors or ARBs. - history of drug or alcohol dependency within the six months prior to signing consent. - concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent. - 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 CCBs.) - non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period. - current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period. - chronic administration of any medication known to affect blood pressure, other than the 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | 1235.6.61005 Boehringer Ingelheim Investigational Site | Elizabeth Vale | South Australia |
| Australia | 1235.6.61003 Boehringer Ingelheim Investigational Site | Gosford | New South Wales |
| Australia | 1235.6.61002 Boehringer Ingelheim Investigational Site | Kippa-Ring | Queensland |
| Australia | 1235.6.61004 Boehringer Ingelheim Investigational Site | Liverpool | New South Wales |
| Australia | 1235.6.61001 Boehringer Ingelheim Investigational Site | Milton | Queensland |
| Austria | 1235.6.43007 Boehringer Ingelheim Investigational Site | Eggenburg | |
| Austria | 1235.6.43006 Boehringer Ingelheim Investigational Site | Hainburg a.d. Donau | |
| Austria | 1235.6.43005 Boehringer Ingelheim Investigational Site | Hartberg | |
| Austria | 1235.6.43001 Boehringer Ingelheim Investigational Site | Wien | |
| Austria | 1235.6.43002 Boehringer Ingelheim Investigational Site | Wien | |
| Austria | 1235.6.43003 Boehringer Ingelheim Investigational Site | Wien | |
| Bulgaria | 1235.6.35912 Boehringer Ingelheim Investigational Site | Bourgas | |
| Bulgaria | 1235.6.35902 Boehringer Ingelheim Investigational Site | Sofia | |
| Bulgaria | 1235.6.35903 Boehringer Ingelheim Investigational Site | Sofia | |
| Bulgaria | 1235.6.35904 Boehringer Ingelheim Investigational Site | Sofia | |
| Bulgaria | 1235.6.35905 Boehringer Ingelheim Investigational Site | Sofia | |
| Bulgaria | 1235.6.35906 Boehringer Ingelheim Investigational Site | Sofia | |
| Bulgaria | 1235.6.35907 Boehringer Ingelheim Investigational Site | Sofia | |
| Bulgaria | 1235.6.35910 Boehringer Ingelheim Investigational Site | Sofia | |
| Bulgaria | 1235.6.35911 Boehringer Ingelheim Investigational Site | Sofia | |
| Bulgaria | 1235.6.35901 Boehringer Ingelheim Investigational Site | Varna | |
| Czech Republic | 1235.6.42002 Boehringer Ingelheim Investigational Site | Benatky nad Jizerou | |
| Czech Republic | 1235.6.42006 Boehringer Ingelheim Investigational Site | Brno | |
| Czech Republic | 1235.6.42001 Boehringer Ingelheim Investigational Site | Plzen | |
| Czech Republic | 1235.6.42003 Boehringer Ingelheim Investigational Site | Praha 5 | |
| Czech Republic | 1235.6.42004 Boehringer Ingelheim Investigational Site | Pribram | |
| Czech Republic | 1235.6.42005 Boehringer Ingelheim Investigational Site | Slany | |
| Czech Republic | 1235.6.42007 Boehringer Ingelheim Investigational Site | Strakonice | |
| Ireland | 1235.6.35304 Wilmer Road | Birr | |
| Ireland | 1235.6.35305 Dr. Ger McLaughlin | Carrigtwohill | |
| Ireland | 1235.6.35302 Slaney Medical Centre | Enniscorthy | |
| Ireland | 1235.6.35303 Gorey Medical Centre, Coral House, | Gorey | |
| Ireland | 1235.6.35306 The Red House Surgery | Mallow | |
| Ireland | 1235.6.35301 Boehringer Ingelheim Investigational Site | New Ross | |
| Italy | 1235.6.39002 Boehringer Ingelheim Investigational Site | Broni (pv) | |
| Italy | 1235.6.39006 Boehringer Ingelheim Investigational Site | Coppito (AQ) | |
| Italy | 1235.6.39001 Boehringer Ingelheim Investigational Site | Ferrara | |
| New Zealand | 1235.6.64003 Boehringer Ingelheim Investigational Site | Dunedin | |
| New Zealand | 1235.6.64002 Boehringer Ingelheim Investigational Site | Otahuhu, Auckland | |
| New Zealand | 1235.6.64001 Boehringer Ingelheim Investigational Site | Tauranga | |
| Russian Federation | 1235.6.70004 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1235.6.70005 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1235.6.70006 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1235.6.70007 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1235.6.70008 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1235.6.70009 Boehringer Ingelheim Investigational Site | Moscow | |
| Russian Federation | 1235.6.70010 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Russian Federation | 1235.6.70011 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Russian Federation | 1235.6.70012 Boehringer Ingelheim Investigational Site | St. Petersburg | |
| Slovakia | 1235.6.42103 Boehringer Ingelheim Investigational Site | Dolny Kubin | |
| Slovakia | 1235.6.42106 Boehringer Ingelheim Investigational Site | Kralovsky Chmlec | |
| Slovakia | 1235.6.42104 Boehringer Ingelheim Investigational Site | Liptovsky Mikulas | |
| Slovakia | 1235.6.42102 Boehringer Ingelheim Investigational Site | Povazska Bystrica | |
| Slovakia | 1235.6.42105 Boehringer Ingelheim Investigational Site | Presov | |
| Slovakia | 1235.6.42101 Boehringer Ingelheim Investigational Site | Trencin | |
| Slovakia | 1235.6.42107 Boehringer Ingelheim Investigational Site | Vrable | |
| Spain | 1235.6.34008 Hospital Municipal de Badalona | Badalona | |
| Spain | 1235.6.34009 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1235.6.34001 Hospital Gral de Jerez de la Frontera | Jerez de la Frontera (Cádiz) | |
| Spain | 1235.6.34006 C.A.P. Mossen Cinto Verdaguer | L'Hospitalet de Llobregat (Barcelona) | |
| Spain | 1235.6.34003 Hospital Doce de Octubre | Madrid | |
| Spain | 1235.6.34004 Hospital La Princesa | Madrid | |
| Spain | 1235.6.34011 Boehringer Ingelheim Investigational Site | Santa Coloma de Gramanet | |
| Switzerland | 1235.6.41005 Boehringer Ingelheim Investigational Site | Gordola | |
| Turkey | 1235.6.90004 Boehringer Ingelheim Investigational Site | Erzurum | |
| Turkey | 1235.6.90003 Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | 1235.6.90005 Boehringer Ingelheim Investigational Site | Istanbul | |
| Turkey | 1235.6.90001 Boehringer Ingelheim Investigational Site | Izmir | |
| Ukraine | 1235.6.38010 Boehringer Ingelheim Investigational Site | Dnepropetrovsk | |
| Ukraine | 1235.6.38001 Boehringer Ingelheim Investigational Site | Kharkov | |
| Ukraine | 1235.6.38003 Boehringer Ingelheim Investigational Site | Kharkov | |
| Ukraine | 1235.6.38008 Boehringer Ingelheim Investigational Site | Kharkov | |
| Ukraine | 1235.6.38011 Boehringer Ingelheim Investigational Site | Kharkov | |
| Ukraine | 1235.6.38004 Boehringer Ingelheim Investigational Site | Kiev | |
| Ukraine | 1235.6.38006 Boehringer Ingelheim Investigational Site | Kiev | |
| Ukraine | 1235.6.38012 Boehringer Ingelheim Investigational Site | Kiev | |
| Ukraine | 1235.6.38013 Boehringer Ingelheim Investigational Site | Kiev | |
| Ukraine | 1235.6.38002 Boehringer Ingelheim Investigational Site | Lvov | |
| Ukraine | 1235.6.38005 Boehringer Ingelheim Investigational Site | Odessa | |
| Ukraine | 1235.6.38009 Boehringer Ingelheim Investigational Site | Odessa | |
| Ukraine | 1235.6.38007 Boehringer Ingelheim Investigational Site | Zaporozhye | |
| United Kingdom | 1235.6.44010 Boehringer Ingelheim Investigational Site | Bexhill | |
| United Kingdom | 1235.6.44008 Boehringer Ingelheim Investigational Site | Blackpool | |
| United Kingdom | 1235.6.44016 Boehringer Ingelheim Investigational Site | Blackpool | |
| United Kingdom | 1235.6.44011 Boehringer Ingelheim Investigational Site | Burbage, Hinkley | |
| United Kingdom | 1235.6.44007 Boehringer Ingelheim Investigational Site | Chestfield, Whitstable | |
| United Kingdom | 1235.6.44005 Boehringer Ingelheim Investigational Site | Chorley | |
| United Kingdom | 1235.6.44002 Boehringer Ingelheim Investigational Site | Edgbaston, Birmingham | |
| United Kingdom | 1235.6.44009 Boehringer Ingelheim Investigational Site | Ely | |
| United Kingdom | 1235.6.44001 Boehringer Ingelheim Investigational Site | Fowey | |
| United Kingdom | 1235.6.44003 Boehringer Ingelheim Investigational Site | Glasgow | |
| United Kingdom | 1235.6.44012 Boehringer Ingelheim Investigational Site | Penzance | |
| United Kingdom | 1235.6.44013 Boehringer Ingelheim Investigational Site | Plymouth | |
| United Kingdom | 1235.6.44004 Boehringer Ingelheim Investigational Site | Reading | |
| United Kingdom | 1235.6.44014 Boehringer Ingelheim Investigational Site | Saltash | |
| United Kingdom | 1235.6.44015 Boehringer Ingelheim Investigational Site | St Stephen, St Austell | |
| United Kingdom | 1235.6.44006 Boehringer Ingelheim Investigational Site | Whitstable |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Australia, Austria, Bulgaria, Czech Republic, Ireland, Italy, New Zealand, Russian Federation, Slovakia, Spain, Switzerland, Turkey, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Trough Seated Diastolic Blood Pressure | Change from baseline to the end of study in trough DBP | Baseline and end of study (8 weeks or last value on treatment) | No |
| Secondary | Change From Baseline in Trough Seated Systolic Blood Pressure | Change from baseline to the end of study in trough SBP | Baseline and end of study (8 weeks or last value on treatment) | No |
| Secondary | Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) | The number of patients who reach the target DBP of <90mmHg | End of study (8 weeks or last value on treatment) | No |
| Secondary | Trough Seated Diastolic Blood Pressure <80 mmHg | The number of patients who reach the target DBP of <80mmHg | End of study (8 weeks or last value on treatment) | No |
| Secondary | Trough Seated DBP Response | The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg | End of study (8 weeks or last value on treatment) | No |
| Secondary | Trough Seated SBP Control | The number of patients who reach the target SBP of <140mmHg | End of study (8 weeks or last value on treatment) | No |
| Secondary | Trough Seated SBP Response | The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg | End of study (8 weeks or last value on treatment) | No |
| Secondary | Trough Seated BP Normality Classes | The number of patients who reach predefined BP categories | End of study (8 weeks or last value on treatment) | No |
| Secondary | Oedema Incidence Rate | The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years) | During randomised treatment period | No |
| Secondary | Peripheral Oedema Incidence Rate | The number of cases of peripheral oedema (expressed as number of cases/100 patient-years) | During randomised treatment period | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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