Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

Condition(s) targeted: Hypertension

Intervention: fixed dose combination of telmisartan+amlodipine (Drug); amlodipine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Study Coordinator, Email: clintriage.rdg@boehringer-ingelheim.com

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.

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

Study design: Treatment, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in seated trough DBP after 8 weeks of randomised treatment

Secondary outcome: Change from baseline in seated SBP at 8 weeks. Proportion of patients achieving DBP control, DBP response, SBP response and proportion having optimal BP, normal BP, high/normal BP and high BP at 8 weeks. Safety and tolerability.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- diagnosis of essential hypertension and blood pressure not adequately controlled

before informed consent (inadequate control defined as seated DBP >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg if treatment-naive).

- 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 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.

Boehringer Ingelheim Study Coordinator, Email: clintriage.rdg@boehringer-ingelheim.com

1235.6.43001 Boehringer Ingelheim Investigational Site, Wien, Austria; Completed

1235.6.43002 Boehringer Ingelheim Investigational Site, Wien, Austria; Completed

1235.6.43003 Boehringer Ingelheim Investigational Site, Wien, Austria; Completed

1235.6.43005 Boehringer Ingelheim Investigational Site, Hartberg, Austria; Completed

1235.6.43006 Boehringer Ingelheim Investigational Site, Hainburg a.d. Donau, Austria; Completed

1235.6.43007 Boehringer Ingelheim Investigational Site, Eggenburg, Austria; Completed

1235.6.35901 Boehringer Ingelheim Investigational Site, Varna, Bulgaria; Completed

1235.6.35902 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Completed

1235.6.35903 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Completed

1235.6.35904 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Completed

1235.6.35905 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Completed

1235.6.35906 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Completed

1235.6.35907 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Completed

1235.6.35910 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Completed

1235.6.35911 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Completed

1235.6.35912 Boehringer Ingelheim Investigational Site, Bourgas, Bulgaria; Completed

1235.6.42001 Boehringer Ingelheim Investigational Site, Plzen, Czech Republic; Completed

1235.6.42002 Boehringer Ingelheim Investigational Site, Benatky nad Jizerou, Czech Republic; Completed

1235.6.42003 Boehringer Ingelheim Investigational Site, Praha 5, Czech Republic; Completed

1235.6.42004 Boehringer Ingelheim Investigational Site, Pribram, Czech Republic; Completed

1235.6.42006 Boehringer Ingelheim Investigational Site, Brno, Czech Republic; Completed

1235.6.42005 Boehringer Ingelheim Investigational Site, Slany, Czech Republic; Completed

1235.6.42007 Boehringer Ingelheim Investigational Site, Strakonice, Czech Republic; Completed

1235.6.35301 Boehringer Ingelheim Investigational Site, New Ross, Ireland; Completed

1235.6.35302 Slaney Medical Centre, Enniscorthy, Ireland; Active, not recruiting

1235.6.35303 Gorey Medical Centre, Coral House,, Gorey, Co. Wexford, Ireland; Completed

1235.6.35304 Wilmer Road, Birr, Ireland; Completed

1235.6.35305 Dr. Ger McLaughlin, Carrigtwohill, Ireland; Completed

1235.6.35306 The Red House Surgery, Mallow, Co. Cork, Ireland; Completed

1235.6.39001 Boehringer Ingelheim Investigational Site, FERRARA, Italy; Completed

1235.6.39002 Boehringer Ingelheim Investigational Site, BRONI (PV), Italy; Completed

1235.6.39006 Boehringer Ingelheim Investigational Site, Coppito (AQ), Italy; Completed

1235.6.64002 Boehringer Ingelheim Investigational Site, Otahuhu, Auckland, New Zealand; Recruiting

1235.6.64003 Boehringer Ingelheim Investigational Site, Dunedin, New Zealand; Recruiting

1235.6.64001 Boehringer Ingelheim Investigational Site, Tauranga, New Zealand; Recruiting

1235.6.70004 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.6.70005 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.6.70006 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Completed

1235.6.70007 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.6.70008 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.6.70009 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.6.70010 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Active, not recruiting

1235.6.70011 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Active, not recruiting

1235.6.70012 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Active, not recruiting

1235.6.42101 Boehringer Ingelheim Investigational Site, Trencin, Slovakia; Completed

1235.6.42102 Boehringer Ingelheim Investigational Site, Povazska Bystrica, Slovakia; Completed

1235.6.42103 Boehringer Ingelheim Investigational Site, Dolny Kubin, Slovakia; Completed

1235.6.42104 Boehringer Ingelheim Investigational Site, Liptovsky Mikulas, Slovakia; Completed

1235.6.42105 Boehringer Ingelheim Investigational Site, Presov, Slovakia; Completed

1235.6.42106 Boehringer Ingelheim Investigational Site, Kralovsky Chmlec, Slovakia; Completed

1235.6.42107 Boehringer Ingelheim Investigational Site, Vrable, Slovakia; Completed

1235.6.34001 Hospital Gral de Jerez de la Frontera, Jerez de la Frontera (C�diz), Spain; Completed

1235.6.34003 Hospital Doce de Octubre, Madrid, Spain; Completed

1235.6.34004 Hospital La Princesa, Madrid, Spain; Completed

1235.6.34006 C.A.P. Mossen Cinto Verdaguer, L'Hospitalet de Llobregat (Barcelona), Spain; Completed

1235.6.34008 Hospital Municipal de Badalona, Badalona, Spain; Completed

1235.6.34009 Boehringer Ingelheim Investigational Site, Barcelona, Spain; Completed

1235.6.34011 Boehringer Ingelheim Investigational Site, Santa Coloma de Gramanet, Spain; Completed

1235.6.41005 Boehringer Ingelheim Investigational Site, Gordola, Switzerland; Recruiting

1235.6.90001 Boehringer Ingelheim Investigational Site, Izmir, Turkey; Active, not recruiting

1235.6.90002 Boehringer Ingelheim Investigational Site, Ankara, Turkey; Recruiting

1235.6.90003 Boehringer Ingelheim Investigational Site, Istanbul, Turkey; Active, not recruiting

1235.6.90004 Boehringer Ingelheim Investigational Site, Erzurum, Turkey; Active, not recruiting

1235.6.90005 Boehringer Ingelheim Investigational Site, Istanbul, Turkey; Active, not recruiting

1235.6.38001 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Completed

1235.6.38002 Boehringer Ingelheim Investigational Site, Lvov, Ukraine; Completed

1235.6.38003 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Completed

1235.6.38004 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Completed

1235.6.38005 Boehringer Ingelheim Investigational Site, Odessa, Ukraine; Completed

1235.6.38006 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Completed

1235.6.38007 Boehringer Ingelheim Investigational Site, Zaporozhye, Ukraine; Completed

1235.6.38008 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Completed

1235.6.38009 Boehringer Ingelheim Investigational Site, Odessa, Ukraine; Completed

1235.6.38010 Boehringer Ingelheim Investigational Site, Dnepropetrovsk, Ukraine; Completed

1235.6.38011 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Completed

1235.6.38012 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Completed

1235.6.38013 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Completed

1235.6.44001 Boehringer Ingelheim Investigational Site, Fowey, United Kingdom; Recruiting

1235.6.44002 Boehringer Ingelheim Investigational Site, Edgbaston, Birmingham, United Kingdom; Recruiting

1235.6.44003 Boehringer Ingelheim Investigational Site, Glasgow, United Kingdom; Recruiting

1235.6.44004 Boehringer Ingelheim Investigational Site, Reading, United Kingdom; Recruiting

1235.6.44005 Boehringer Ingelheim Investigational Site, Chorley, United Kingdom; Recruiting

1235.6.44006 Boehringer Ingelheim Investigational Site, Whitstable, United Kingdom; Recruiting

1235.6.44007 Boehringer Ingelheim Investigational Site, Chestfield, Whitstable, United Kingdom; Recruiting

1235.6.44008 Boehringer Ingelheim Investigational Site, Blackpool, United Kingdom; Recruiting

1235.6.44009 Boehringer Ingelheim Investigational Site, Ely, United Kingdom; Recruiting

1235.6.44010 Boehringer Ingelheim Investigational Site, Bexhill, United Kingdom; Recruiting

1235.6.44011 Boehringer Ingelheim Investigational Site, Hinkley, United Kingdom; Recruiting

1235.6.44012 Boehringer Ingelheim Investigational Site, Penzance, United Kingdom; Recruiting

1235.6.44013 Boehringer Ingelheim Investigational Site, Plymouth, United Kingdom; Recruiting

1235.6.44014 Boehringer Ingelheim Investigational Site, Saltash, United Kingdom; Recruiting

1235.6.44015 Boehringer Ingelheim Investigational Site, St. Austell, United Kingdom; Recruiting

1235.6.44016 Boehringer Ingelheim Investigational Site, Blackpool, United Kingdom; Active, not recruiting

1235.6.61003 Boehringer Ingelheim Investigational Site, Gosford, New South Wales, Australia; Recruiting

1235.6.61004 Boehringer Ingelheim Investigational Site, Liverpool, New South Wales, Australia; Recruiting

1235.6.61001 Boehringer Ingelheim Investigational Site, Milton, Queensland, Australia; Recruiting

1235.6.61002 Boehringer Ingelheim Investigational Site, Kippa-Ring, Queensland, Australia; Recruiting

1235.6.61005 Boehringer Ingelheim Investigational Site, Elizabeth Vale, South Australia, Australia; Recruiting

Starting date: October 2007
Last updated: October 14, 2008