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

NCT00624052 | Completed Phase 3 Results

• 1 other identifier: 1235.8
• Study Type: interventional
• Target: 838
• Locations: 11 countries
• Sites: 87

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).

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Trough Seated Diastolic Blood Pressure (DBP) Control

  The number of patients who reached the target DBP of \<90mmHg

  End of study (34 weeks or last value on treatment)

Secondary Outcomes (13)

• Trough Seated Systolic Blood Pressure (SBP) Control

  End of study (34 weeks or last value on treatment)

• 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 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)

• 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 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)

Interventions

fixed-dose combination of telmisartan 40mg+amlodipine 10mg DRUG

fixed-dose combination of telmisartan 80mg+amlodipine10mg 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (92)

1235.8.61003 Boehringer Ingelheim Investigational Site

Gosford, New South Wales, Australia

Location

1235.8.61004 Boehringer Ingelheim Investigational Site

Liverpool, New South Wales, Australia

Location

1235.8.61002 Boehringer Ingelheim Investigational Site

Kippa-Ring, Queensland, Australia

Location

1235.8.61001 Boehringer Ingelheim Investigational Site

Milton, Queensland, Australia

Location

1235.8.61005 Boehringer Ingelheim Investigational Site

Elizabeth Vale, South Australia, Australia

Location

1235.8.43007 Boehringer Ingelheim Investigational Site

Eggenburg, Austria

Location

1235.8.43006 Boehringer Ingelheim Investigational Site

Hainburg A.d. Donau, Austria

Location

1235.8.43001 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1235.8.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1235.8.43003 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1235.8.35912 Boehringer Ingelheim Investigational Site

Burgas, Bulgaria

Location

1235.8.35902 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.8.35903 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.8.35904 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.8.35905 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.8.35906 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.8.35907 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.8.35910 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.8.35911 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1235.8.42002 Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, Czechia

Location

1235.8.42006 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1235.8.42001 Boehringer Ingelheim Investigational Site

Pilsen, Czechia

Location

1235.8.42003 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1235.8.42004 Boehringer Ingelheim Investigational Site

Příbram, Czechia

Location

1235.8.42005 Boehringer Ingelheim Investigational Site

Slaný, Czechia

Location

1235.8.42007 Boehringer Ingelheim Investigational Site

Strakonice, Czechia

Location

1235.8.35304 Boehringer Ingelheim Investigational Site

Birr, Ireland

Location

1235.8.35305 Boehringer Ingelheim Investigational Site

Carrigtowhill, Ireland

Location

1235.8.35303 Boehringer Ingelheim Investigational Site

Gorey, Co. Wexford, Ireland

Location

1235.8.35306 Boehringer Ingelheim Investigational Site

Mallow, Ireland

Location

1235.8.35301 Boehringer Ingelheim Investigational Site

New Ross, Ireland

Location

1235.8.39002 Boehringer Ingelheim Investigational Site

Broni (pv), Italy

Location

1235.8.39006 Boehringer Ingelheim Investigational Site

Coppito (AQ), Italy

Location

1235.8.39001 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

1235.8.64003 Boehringer Ingelheim Investigational Site

Dunedin, New Zealand

Location

1235.8.64002 Boehringer Ingelheim Investigational Site

Otahuhu, Auckland, New Zealand

Location

1235.8.64001 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand

Location

1235.8.70004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.8.70005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.8.70006 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.8.70007 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.8.70008 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.8.70009 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1235.8.70010 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.8.70011 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.8.70012 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1235.8.42103 Boehringer Ingelheim Investigational Site

Dolný Kubín, Slovakia

Location

1235.8.42106 Boehringer Ingelheim Investigational Site

Kralovsky Chmlec, Slovakia

Location

1235.8.42104 Boehringer Ingelheim Investigational Site

Liptovský Mikuláš, Slovakia

Location

1235.8.42102 Boehringer Ingelheim Investigational Site

Považská Bystrica, Slovakia

Location

1235.8.42105 Boehringer Ingelheim Investigational Site

Prešov, Slovakia

Location

1235.8.42101 Boehringer Ingelheim Investigational Site

Trenčín, Slovakia

Location

1235.8.42107 Boehringer Ingelheim Investigational Site

Vráble, Slovakia

Location

1235.8.34008 Boehringer Ingelheim Investigational Site

Badalona, Spain

Location

1235.8.34010 Boehringer Ingelheim Investigational Site

Badalona, Spain

Location

1235.8.34009 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1235.8.34001 Boehringer Ingelheim Investigational Site

Jerez de La Frontera (Cádiz), Spain

Location

1235.8.34006 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), Spain

Location

1235.8.34003 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1235.8.34004 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1235.8.34012 Boehringer Ingelheim Investigational Site

Mataró, Spain

Location

1235.8.34002 Boehringer Ingelheim Investigational Site

Oviedo, Spain

Location

1235.8.34005 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet, Spain

Location

1235.8.34011 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet, Spain

Location

1235.8.38010 Boehringer Ingelheim Investigational Site

Dnipro, Ukraine

Location

1235.8.38001 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.8.38003 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.8.38008 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.8.38011 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1235.8.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.8.38006 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.8.38012 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.8.38013 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1235.8.38002 Boehringer Ingelheim Investigational Site

Lviv, Ukraine

Location

1235.8.38005 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1235.8.38009 Boehringer Ingelheim Investigational Site

Odesa, Ukraine

Location

1235.8.38007 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

1235.8.44010 Boehringer Ingelheim Investigational Site

Bexhill-on-Sea, United Kingdom

Location

1235.8.44008 Boehringer Ingelheim Investigational Site

Blackpool, United Kingdom

Location

1235.8.44016 Boehringer Ingelheim Investigational Site

Blackpool, United Kingdom

Location

1235.8.44011 Boehringer Ingelheim Investigational Site

Burbage, United Kingdom

Location

1235.8.44007 Boehringer Ingelheim Investigational Site

Chestfield, Whitstable, United Kingdom

Location

1235.8.44005 Boehringer Ingelheim Investigational Site

Chorley, United Kingdom

Location

1235.8.44002 Boehringer Ingelheim Investigational Site

Edgbaston, Birmingham, United Kingdom

Location

1235.8.44009 Boehringer Ingelheim Investigational Site

Ely, United Kingdom

Location

1235.8.44001 Boehringer Ingelheim Investigational Site

Fowey, United Kingdom

Location

1235.8.44003 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

1235.8.44012 Boehringer Ingelheim Investigational Site

Penzance, United Kingdom

Location

1235.8.44013 Boehringer Ingelheim Investigational Site

Plymouth, United Kingdom

Location

1235.8.44004 Boehringer Ingelheim Investigational Site

Reading, United Kingdom

Location

1235.8.44015 Boehringer Ingelheim Investigational Site

St Austell, United Kingdom

Location

1235.8.44006 Boehringer Ingelheim Investigational Site

Whitstable, United Kingdom

Location

Related Publications (1)

• Neldam S, Edwards C, Lang M, Jones R; TEAMSTA-5 and TEAMSTA-10 Investigators. Long-Term Tolerability and Efficacy of Single-Pill Combinations of Telmisartan 40-80 mg Plus Amlodipine 5 or 10 mg in Patients Whose Blood Pressure Was Not Initially Controlled by Amlodipine 5-10 mg: Open-Label, Long-Term Follow-Ups of the TEAMSTA-5 and TEAMSTA-10 Studies. Curr Ther Res Clin Exp. 2012 Feb;73(1-2):65-84. doi: 10.1016/j.curtheres.2012.02.004.

  PMID: 24653513 DERIVED

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
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 26, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2009
• Last Updated: May 20, 2014
• Results First Posted: March 25, 2010

Record last verified: 2014-05

Locations

BU (9); IE (5); RU (9); ES (11); SL (7); CZ (7); AU (5); IT (3); NZ (3); UA (13); GB (15)