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

NCT00553267 | Completed Phase 3 Results

• 2 other identifiers: 1235.6EUDRACT 2007-002421-68
• Study Type: interventional
• Target: 947
• Locations: 13 countries
• Sites: 92

Brief Summary

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• Change From Baseline in Trough Seated Systolic Blood Pressure

  Baseline and end of study (8 weeks or last value on treatment)

• Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg)

  End of study (8 weeks or last value on treatment)

• Trough Seated Diastolic Blood Pressure <80 mmHg

  End of study (8 weeks or last value on treatment)

• Trough Seated DBP Response

  End of study (8 weeks or last value on treatment)

• Trough Seated SBP Control

  End of study (8 weeks or last value on treatment)

Interventions

fixed dose combination of telmisartan+amlodipine DRUG

amlodipine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (97)

1235.6.61003 Boehringer Ingelheim Investigational Site

Gosford, New South Wales, Australia

Location

1235.6.61004 Boehringer Ingelheim Investigational Site

Liverpool, New South Wales, Australia

Location

1235.6.61002 Boehringer Ingelheim Investigational Site

Kippa-Ring, Queensland, Australia

Location

1235.6.61001 Boehringer Ingelheim Investigational Site

Milton, Queensland, Australia

Location

1235.6.61005 Boehringer Ingelheim Investigational Site

Elizabeth Vale, South Australia, Australia

Location

1235.6.43007 Boehringer Ingelheim Investigational Site

Eggenburg, Austria

Location

1235.6.43006 Boehringer Ingelheim Investigational Site

Hainburg A.d. Donau, Austria

Location

1235.6.43005 Boehringer Ingelheim Investigational Site

Hartberg, Austria

Location

1235.6.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1235.6.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1235.6.43003 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1235.6.35912 Boehringer Ingelheim Investigational Site

Burgas, Bulgaria

Location

1235.6.35902 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.6.35903 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.6.35904 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.6.35905 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.6.35906 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.6.35907 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.6.35910 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.6.35911 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.6.35901 Boehringer Ingelheim Investigational Site

Varna, Bulgaria

Location

1235.6.42002 Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, Czechia

Location

1235.6.42006 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1235.6.42001 Boehringer Ingelheim Investigational Site

Pilsen, Czechia

Location

1235.6.42003 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1235.6.42004 Boehringer Ingelheim Investigational Site

Příbram, Czechia

Location

1235.6.42005 Boehringer Ingelheim Investigational Site

Slaný, Czechia

Location

1235.6.42007 Boehringer Ingelheim Investigational Site

Strakonice, Czechia

Location

1235.6.35304 Wilmer Road

Birr, Ireland

Location

1235.6.35305 Dr. Ger McLaughlin

Carrigtohill, Ireland

Location

1235.6.35302 Slaney Medical Centre

Enniscorthy, Ireland

Location

1235.6.35303 Gorey Medical Centre, Coral House,

Gorey, Ireland

Location

1235.6.35306 The Red House Surgery

Mallow, Ireland

Location

1235.6.35301 Boehringer Ingelheim Investigational Site

New Ross, Ireland

Location

1235.6.39002 Boehringer Ingelheim Investigational Site

Broni (pv), Italy

Location

1235.6.39006 Boehringer Ingelheim Investigational Site

Coppito (AQ), Italy

Location

1235.6.39001 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

1235.6.64003 Boehringer Ingelheim Investigational Site

Dunedin, New Zealand

Location

1235.6.64002 Boehringer Ingelheim Investigational Site

Otahuhu, Auckland, New Zealand

Location

1235.6.64001 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand

Location

1235.6.70004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.6.70005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.6.70006 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.6.70007 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.6.70008 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.6.70009 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.6.70010 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.6.70011 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.6.70012 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.6.42103 Boehringer Ingelheim Investigational Site

Dolný Kubín, Slovakia

Location

1235.6.42106 Boehringer Ingelheim Investigational Site

Kralovsky Chmlec, Slovakia

Location

1235.6.42104 Boehringer Ingelheim Investigational Site

Liptovský Mikuláš, Slovakia

Location

1235.6.42102 Boehringer Ingelheim Investigational Site

Považská Bystrica, Slovakia

Location

1235.6.42105 Boehringer Ingelheim Investigational Site

Prešov, Slovakia

Location

1235.6.42101 Boehringer Ingelheim Investigational Site

Trenčín, Slovakia

Location

1235.6.42107 Boehringer Ingelheim Investigational Site

Vráble, Slovakia

Location

1235.6.34008 Hospital Municipal de Badalona

Badalona, Spain

Location

1235.6.34009 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1235.6.34001 Hospital Gral de Jerez de la Frontera

Jerez de La Frontera (Cádiz), Spain

Location

1235.6.34006 C.A.P. Mossen Cinto Verdaguer

L'Hospitalet de Llobregat (Barcelona), Spain

Location

1235.6.34003 Hospital Doce de Octubre

Madrid, Spain

Location

1235.6.34004 Hospital La Princesa

Madrid, Spain

Location

1235.6.34011 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet, Spain

Location

1235.6.41005 Boehringer Ingelheim Investigational Site

Gordola, Switzerland

Location

1235.6.90004 Boehringer Ingelheim Investigational Site

Erzurum, Turkey (Türkiye)

Location

1235.6.90003 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1235.6.90005 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1235.6.90001 Boehringer Ingelheim Investigational Site

Izmir, Turkey (Türkiye)

Location

1235.6.38010 Boehringer Ingelheim Investigational Site

Dnipro, Ukraine

Location

1235.6.38001 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.6.38003 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.6.38008 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.6.38011 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.6.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.6.38006 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.6.38012 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.6.38013 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.6.38002 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1235.6.38005 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1235.6.38009 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1235.6.38007 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

1235.6.44010 Boehringer Ingelheim Investigational Site

Bexhill-on-Sea, United Kingdom

Location

1235.6.44008 Boehringer Ingelheim Investigational Site

Blackpool, United Kingdom

Location

1235.6.44016 Boehringer Ingelheim Investigational Site

Blackpool, United Kingdom

Location

1235.6.44011 Boehringer Ingelheim Investigational Site

Burbage, Hinkley, United Kingdom

Location

1235.6.44007 Boehringer Ingelheim Investigational Site

Chestfield, Whitstable, United Kingdom

Location

1235.6.44005 Boehringer Ingelheim Investigational Site

Chorley, United Kingdom

Location

1235.6.44002 Boehringer Ingelheim Investigational Site

Edgbaston, Birmingham, United Kingdom

Location

1235.6.44009 Boehringer Ingelheim Investigational Site

Ely, United Kingdom

Location

1235.6.44001 Boehringer Ingelheim Investigational Site

Fowey, United Kingdom

Location

1235.6.44003 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

1235.6.44012 Boehringer Ingelheim Investigational Site

Penzance, United Kingdom

Location

1235.6.44013 Boehringer Ingelheim Investigational Site

Plymouth, United Kingdom

Location

1235.6.44004 Boehringer Ingelheim Investigational Site

Reading, United Kingdom

Location

1235.6.44015 Boehringer Ingelheim Investigational Site

Saint Stephen, Saint Austell, United Kingdom

Location

1235.6.44014 Boehringer Ingelheim Investigational Site

Saltash, United Kingdom

Location

1235.6.44006 Boehringer Ingelheim Investigational Site

Whitstable, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 8, 2007
• First Posted: November 5, 2007
• Study Start: November 1, 2007
• Primary Completion: October 1, 2008
• Last Updated: February 13, 2014
• Results First Posted: December 22, 2009

Record last verified: 2013-12

Locations

CZ (7); TU (4); AU (6); BU (10); IE (6); IT (3); NZ (3); UA (13); GB (16); RU (9); SL (7); CH (1); ES (7)