26-Week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension

Condition(s) targeted: Hypertension

Intervention: fixed-dose combination of telmisartan 40mg+amlodipine 10mg (Drug); fixed-dose combination of telmisartan 80mg+amlodipine10mg (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, Phone: 1-800-243-0127, Ext: Option 4, Email: clintriage.rdg@boehringer-ingelheim.com

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations T40/A10 or 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 diastolic blood pressure (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).

Official title: An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg + Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg + Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension

Study design: Treatment, Safety/Efficacy Study

Primary outcome: Proportion of patients achieving diastolic blood pressure control

Secondary outcome: Change from baseline in seated blood pressure

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

Criteria:

Inclusion Criteria:

- diagnosis of essential hypertension

Exclusion Criteria:

- 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 T40/A10

or T80/A10.

- discontinuation from the preceding trial.

- known or suspected secondary hypertension.

- mean seated SBP >= 180 mmHg and/or mean seated 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 ACE inhibitors or 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 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.

Boehringer Ingelheim Study Coordinator, Phone: 1-800-243-0127, Ext: Option 4, Email: clintriage.rdg@boehringer-ingelheim.com

1235.8.43007 Boehringer Ingelheim Investigational Site, Eggenburg, Austria; Active, not recruiting

1235.8.43001 Boehringer Ingelheim Investigational Site, Wien, Austria; Active, not recruiting

1235.8.43002 Boehringer Ingelheim Investigational Site, Wien, Austria; Active, not recruiting

1235.8.43003 Boehringer Ingelheim Investigational Site, Wien, Austria; Active, not recruiting

1235.8.43006 Boehringer Ingelheim Investigational Site, Hainburg a.d. Donau, Austria; Active, not recruiting

1235.8.35902 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Active, not recruiting

1235.8.35903 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Active, not recruiting

1235.8.35904 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Active, not recruiting

1235.8.35905 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Active, not recruiting

1235.8.35906 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Active, not recruiting

1235.8.35907 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Active, not recruiting

1235.8.35910 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Active, not recruiting

1235.8.35911 Boehringer Ingelheim Investigational Site, Sofia, Bulgaria; Active, not recruiting

1235.8.35912 Boehringer Ingelheim Investigational Site, Bourgas, Bulgaria; Active, not recruiting

1235.8.42001 Boehringer Ingelheim Investigational Site, Plzen, Czech Republic; Active, not recruiting

1235.8.42002 Boehringer Ingelheim Investigational Site, Benatky nad Jizerou, Czech Republic; Active, not recruiting

1235.8.42003 Boehringer Ingelheim Investigational Site, Praha 5, Czech Republic; Active, not recruiting

1235.8.42004 Boehringer Ingelheim Investigational Site, Pribram, Czech Republic; Active, not recruiting

1235.8.42006 Boehringer Ingelheim Investigational Site, Brno, Czech Republic; Active, not recruiting

1235.8.42007 Boehringer Ingelheim Investigational Site, Strakonice, Czech Republic; Active, not recruiting

1235.8.42005 Boehringer Ingelheim Investigational Site, Slany, Czech Republic; Active, not recruiting

1235.8.35301 Boehringer Ingelheim Investigational Site, New Ross, Ireland; Recruiting

1235.8.35303 Boehringer Ingelheim Investigational Site, Gorey, Co. Wexford, Ireland; Recruiting

1235.8.35304 Boehringer Ingelheim Investigational Site, Birr, Ireland; Recruiting

1235.8.35305 Boehringer Ingelheim Investigational Site, Carrigtowhill, Ireland; Recruiting

1235.8.35306 Boehringer Ingelheim Investigational Site, Mallow, Ireland; Recruiting

1235.8.39006 Boehringer Ingelheim Investigational Site, Coppito (AQ), Italy; Active, not recruiting

1235.8.39001 Boehringer Ingelheim Investigational Site, FERRARA, Italy; Recruiting

1235.8.39002 Boehringer Ingelheim Investigational Site, BRONI (PV), Italy; Recruiting

1235.8.64001 Boehringer Ingelheim Investigational Site, Tauranga, New Zealand; Active, not recruiting

1235.8.64002 Boehringer Ingelheim Investigational Site, Otahuhu, Auckland, New Zealand; Active, not recruiting

1235.8.64003 Boehringer Ingelheim Investigational Site, Dunedin, New Zealand; Active, not recruiting

1235.8.70004 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.8.70005 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.8.70006 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.8.70007 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.8.70008 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.8.70009 Boehringer Ingelheim Investigational Site, Moscow, Russian Federation; Active, not recruiting

1235.8.70010 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Active, not recruiting

1235.8.70011 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Active, not recruiting

1235.8.70012 Boehringer Ingelheim Investigational Site, St. Petersburg, Russian Federation; Active, not recruiting

1235.8.42101 Boehringer Ingelheim Investigational Site, Trencin, Slovakia; Active, not recruiting

1235.8.42102 Boehringer Ingelheim Investigational Site, Povazska Bystrica, Slovakia; Active, not recruiting

1235.8.42103 Boehringer Ingelheim Investigational Site, Dolny Kubin, Slovakia; Active, not recruiting

1235.8.42104 Boehringer Ingelheim Investigational Site, Liptovsky Mikulas, Slovakia; Active, not recruiting

1235.8.42105 Boehringer Ingelheim Investigational Site, Presov, Slovakia; Active, not recruiting

1235.8.42106 Boehringer Ingelheim Investigational Site, Kralovsky Chmlec, Slovakia; Active, not recruiting

1235.8.42107 Boehringer Ingelheim Investigational Site, Vrable, Slovakia; Active, not recruiting

1235.8.34001 Boehringer Ingelheim Investigational Site, Jerez de la Frontera (Cádiz), Spain; Recruiting

1235.8.34002 Boehringer Ingelheim Investigational Site, Oviedo, Spain; Withdrawn

1235.8.34003 Boehringer Ingelheim Investigational Site, Madrid, Spain; Recruiting

1235.8.34004 Boehringer Ingelheim Investigational Site, Madrid, Spain; Recruiting

1235.8.34005 Boehringer Ingelheim Investigational Site, Santa Coloma de Gramanet, Spain; Withdrawn

1235.8.34006 Boehringer Ingelheim Investigational Site, L'Hospitalet de Llobregat (Barcelona), Spain; Recruiting

1235.8.34008 Boehringer Ingelheim Investigational Site, Badalona, Spain; Recruiting

1235.8.34009 Boehringer Ingelheim Investigational Site, Barcelona, Spain; Recruiting

1235.8.34010 Boehringer Ingelheim Investigational Site, Badalona, Spain; Withdrawn

1235.8.34011 Boehringer Ingelheim Investigational Site, Santa Coloma de Gramanet, Spain; Recruiting

1235.8.34012 Boehringer Ingelheim Investigational Site, Mataró, Spain; Withdrawn

1235.8.38001 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Active, not recruiting

1235.8.38002 Boehringer Ingelheim Investigational Site, Lvov, Ukraine; Active, not recruiting

1235.8.38003 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Active, not recruiting

1235.8.38004 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Active, not recruiting

1235.8.38005 Boehringer Ingelheim Investigational Site, Odessa, Ukraine; Active, not recruiting

1235.8.38006 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Active, not recruiting

1235.8.38008 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Active, not recruiting

1235.8.38009 Boehringer Ingelheim Investigational Site, Odessa, Ukraine; Active, not recruiting

1235.8.38010 Boehringer Ingelheim Investigational Site, Dnepropetrovsk, Ukraine; Active, not recruiting

1235.8.38011 Boehringer Ingelheim Investigational Site, Kharkov, Ukraine; Active, not recruiting

1235.8.38012 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Active, not recruiting

1235.8.38013 Boehringer Ingelheim Investigational Site, Kiev, Ukraine; Active, not recruiting

1235.8.38007 Boehringer Ingelheim Investigational Site, Zaporozhye, Ukraine; Active, not recruiting

1235.8.44001 Boehringer Ingelheim Investigational Site, Fowey, United Kingdom; Recruiting

1235.8.44002 Boehringer Ingelheim Investigational Site, Edgbaston, Birmingham, United Kingdom; Recruiting

1235.8.44003 Boehringer Ingelheim Investigational Site, GLASGOW, United Kingdom; Recruiting

1235.8.44004 Boehringer Ingelheim Investigational Site, Reading, United Kingdom; Recruiting

1235.8.44005 Boehringer Ingelheim Investigational Site, Chorley, United Kingdom; Recruiting

1235.8.44006 Boehringer Ingelheim Investigational Site, Whitstable, United Kingdom; Recruiting

1235.8.44007 Boehringer Ingelheim Investigational Site, Chestfield, Whitstable, United Kingdom; Recruiting

1235.8.44008 Boehringer Ingelheim Investigational Site, Blackpool, United Kingdom; Recruiting

1235.8.44012 Boehringer Ingelheim Investigational Site, Penzance, United Kingdom; Recruiting

1235.8.44015 Boehringer Ingelheim Investigational Site, St. Austell, United Kingdom; Recruiting

1235.8.44009 Boehringer Ingelheim Investigational Site, Ely, United Kingdom; Recruiting

1235.8.44011 Boehringer Ingelheim Investigational Site, Burbage, United Kingdom; Recruiting

1235.8.44016 Boehringer Ingelheim Investigational Site, Blackpool, United Kingdom; Recruiting

1235.8.44010 Boehringer Ingelheim Investigational Site, Bexhill, United Kingdom; Active, not recruiting

1235.8.44013 Boehringer Ingelheim Investigational Site, Plymouth, United Kingdom; Recruiting

1235.8.61003 Boehringer Ingelheim Investigational Site, Gosford, New South Wales, Australia; Recruiting

1235.8.61004 Boehringer Ingelheim Investigational Site, Liverpool, New South Wales, Australia; Recruiting

1235.8.61001 Boehringer Ingelheim Investigational Site, Milton, Queensland, Australia; Recruiting

1235.8.61002 Boehringer Ingelheim Investigational Site, Kippa-Ring, Queensland, Australia; Recruiting

1235.8.61005 Boehringer Ingelheim Investigational Site, Elizabeth Vale, South Australia, Australia; Recruiting

Starting date: March 2008
Last updated: February 5, 2009