MedDataX Logo

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

NCT ID: NCT00624052

Last Updated: 2014-05-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

838 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00553267

Hypertension
COMPLETED PHASE3

Open Label Study Telmisartan and Amlodipine in Hypertension

NCT00614380

Hypertension
COMPLETED PHASE3

Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

NCT00558428

Hypertension
COMPLETED PHASE3

Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

NCT00860262

Hypertension
COMPLETED PHASE3

Telmisartan+Amlodipine Fixed Dose Combination in Hypertension

NCT01204398

Hypertension
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

fixed-dose combination of telmisartan 80mg+amlodipine10mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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.
* known allergic hypersensitivity to any component of the formulations under investigation. \[Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine calcium channel blockers (CCBs).\] 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boehringer Ingelheim

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1235.8.61003 Boehringer Ingelheim Investigational Site

Gosford, New South Wales, Australia

Site Status

1235.8.61004 Boehringer Ingelheim Investigational Site

Liverpool, New South Wales, Australia

Site Status

1235.8.61002 Boehringer Ingelheim Investigational Site

Kippa-Ring, Queensland, Australia

Site Status

1235.8.61001 Boehringer Ingelheim Investigational Site

Milton, Queensland, Australia

Site Status

1235.8.61005 Boehringer Ingelheim Investigational Site

Elizabeth Vale, South Australia, Australia

Site Status

1235.8.43007 Boehringer Ingelheim Investigational Site

Eggenburg, , Austria

Site Status

1235.8.43006 Boehringer Ingelheim Investigational Site

Hainburg A.d. Donau, , Austria

Site Status

1235.8.43001 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1235.8.43002 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1235.8.43003 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1235.8.35912 Boehringer Ingelheim Investigational Site

Burgas, , Bulgaria

Site Status

1235.8.35902 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1235.8.35903 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1235.8.35904 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1235.8.35905 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1235.8.35906 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1235.8.35907 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1235.8.35910 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1235.8.35911 Boehringer Ingelheim Investigational Site

Sofia, , Bulgaria

Site Status

1235.8.42002 Boehringer Ingelheim Investigational Site

Benátky nad Jizerou, , Czechia

Site Status

1235.8.42006 Boehringer Ingelheim Investigational Site

Brno, , Czechia

Site Status

1235.8.42001 Boehringer Ingelheim Investigational Site

Pilsen, , Czechia

Site Status

1235.8.42003 Boehringer Ingelheim Investigational Site

Prague, , Czechia

Site Status

1235.8.42004 Boehringer Ingelheim Investigational Site

Příbram, , Czechia

Site Status

1235.8.42005 Boehringer Ingelheim Investigational Site

Slaný, , Czechia

Site Status

1235.8.42007 Boehringer Ingelheim Investigational Site

Strakonice, , Czechia

Site Status

1235.8.35304 Boehringer Ingelheim Investigational Site

Birr, , Ireland

Site Status

1235.8.35305 Boehringer Ingelheim Investigational Site

Carrigtowhill, , Ireland

Site Status

1235.8.35303 Boehringer Ingelheim Investigational Site

Gorey, Co. Wexford, , Ireland

Site Status

1235.8.35306 Boehringer Ingelheim Investigational Site

Mallow, , Ireland

Site Status

1235.8.35301 Boehringer Ingelheim Investigational Site

New Ross, , Ireland

Site Status

1235.8.39002 Boehringer Ingelheim Investigational Site

Broni (pv), , Italy

Site Status

1235.8.39006 Boehringer Ingelheim Investigational Site

Coppito (AQ), , Italy

Site Status

1235.8.39001 Boehringer Ingelheim Investigational Site

Ferrara, , Italy

Site Status

1235.8.64003 Boehringer Ingelheim Investigational Site

Dunedin, , New Zealand

Site Status

1235.8.64002 Boehringer Ingelheim Investigational Site

Otahuhu, Auckland, , New Zealand

Site Status

1235.8.64001 Boehringer Ingelheim Investigational Site

Tauranga, , New Zealand

Site Status

1235.8.70004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1235.8.70005 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1235.8.70006 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1235.8.70007 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1235.8.70008 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1235.8.70009 Boehringer Ingelheim Investigational Site

Moscow, , Russia

Site Status

1235.8.70010 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1235.8.70011 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1235.8.70012 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1235.8.42103 Boehringer Ingelheim Investigational Site

Dolný Kubín, , Slovakia

Site Status

1235.8.42106 Boehringer Ingelheim Investigational Site

Kralovsky Chmlec, , Slovakia

Site Status

1235.8.42104 Boehringer Ingelheim Investigational Site

Liptovský Mikuláš, , Slovakia

Site Status

1235.8.42102 Boehringer Ingelheim Investigational Site

Považská Bystrica, , Slovakia

Site Status

1235.8.42105 Boehringer Ingelheim Investigational Site

Prešov, , Slovakia

Site Status

1235.8.42101 Boehringer Ingelheim Investigational Site

Trenčín, , Slovakia

Site Status

1235.8.42107 Boehringer Ingelheim Investigational Site

Vráble, , Slovakia

Site Status

1235.8.34008 Boehringer Ingelheim Investigational Site

Badalona, , Spain

Site Status

1235.8.34010 Boehringer Ingelheim Investigational Site

Badalona, , Spain

Site Status

1235.8.34009 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1235.8.34001 Boehringer Ingelheim Investigational Site

Jerez de La Frontera (Cádiz), , Spain

Site Status

1235.8.34006 Boehringer Ingelheim Investigational Site

L'Hospitalet de Llobregat (Barcelona), , Spain

Site Status

1235.8.34003 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1235.8.34004 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1235.8.34012 Boehringer Ingelheim Investigational Site

Mataró, , Spain

Site Status

1235.8.34002 Boehringer Ingelheim Investigational Site

Oviedo, , Spain

Site Status

1235.8.34005 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet, , Spain

Site Status

1235.8.34011 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet, , Spain

Site Status

1235.8.38010 Boehringer Ingelheim Investigational Site

Dnipro, , Ukraine

Site Status

1235.8.38001 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1235.8.38003 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1235.8.38008 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1235.8.38011 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1235.8.38004 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.8.38006 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.8.38012 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.8.38013 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

1235.8.38002 Boehringer Ingelheim Investigational Site

Lviv, , Ukraine

Site Status

1235.8.38005 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1235.8.38009 Boehringer Ingelheim Investigational Site

Odesa, , Ukraine

Site Status

1235.8.38007 Boehringer Ingelheim Investigational Site

Zaporizhzhya, , Ukraine

Site Status

1235.8.44010 Boehringer Ingelheim Investigational Site

Bexhill-on-Sea, , United Kingdom

Site Status

1235.8.44008 Boehringer Ingelheim Investigational Site

Blackpool, , United Kingdom

Site Status

1235.8.44016 Boehringer Ingelheim Investigational Site

Blackpool, , United Kingdom

Site Status

1235.8.44011 Boehringer Ingelheim Investigational Site

Burbage, , United Kingdom

Site Status

1235.8.44007 Boehringer Ingelheim Investigational Site

Chestfield, Whitstable, , United Kingdom

Site Status

1235.8.44005 Boehringer Ingelheim Investigational Site

Chorley, , United Kingdom

Site Status

1235.8.44002 Boehringer Ingelheim Investigational Site

Edgbaston, Birmingham, , United Kingdom

Site Status

1235.8.44009 Boehringer Ingelheim Investigational Site

Ely, , United Kingdom

Site Status

1235.8.44001 Boehringer Ingelheim Investigational Site

Fowey, , United Kingdom

Site Status

1235.8.44003 Boehringer Ingelheim Investigational Site

Glasgow, , United Kingdom

Site Status

1235.8.44012 Boehringer Ingelheim Investigational Site

Penzance, , United Kingdom

Site Status

1235.8.44013 Boehringer Ingelheim Investigational Site

Plymouth, , United Kingdom

Site Status

1235.8.44004 Boehringer Ingelheim Investigational Site

Reading, , United Kingdom

Site Status

1235.8.44015 Boehringer Ingelheim Investigational Site

St Austell, , United Kingdom

Site Status

1235.8.44006 Boehringer Ingelheim Investigational Site

Whitstable, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia Austria Bulgaria Czechia Ireland Italy New Zealand Russia Slovakia Spain Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24653513 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1235.8

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
NCT00877929 COMPLETED PHASE3
Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of 40 mg Telmisartan/5 mg Amlodipine and 80 mg Telmisartan/5 mg Amlodipine in Healthy Male Volunteers
NCT02194309 COMPLETED PHASE1
Open-label Follow-up Trial of Fixed Dose Combination of Telmisartan + Hydrochlorothiazide in Hypertensive Patients
NCT00267943 COMPLETED PHASE3
Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine
NCT01911780 COMPLETED PHASE3
An Eight-week Randomized,Double-blind Study to Evaluate the Efficacy and Safety of Fixed-dose Combinations of T80+A5 Versus A5 Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With A5 Monotherapy
NCT01103960 COMPLETED PHASE3
Filtered Trial for Telmisartan 40mg Non-responder
NCT00550953 COMPLETED PHASE3
An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
NCT00618774 COMPLETED PHASE3
Trial of Telmisartan 80 mg/HCTZ 12.5 mg and Telmisartan 40 mg/HCTZ 12.5 mg in Patients With Hypertension
NCT00326768 COMPLETED PHASE3
Bioequivalence Study of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers
NCT02259829 COMPLETED PHASE1
Telmisartan (Micardis) and Amlodipine (Norvasc) - Factorial Design Study for the Treatment of Hypertension
NCT00281580 COMPLETED PHASE3
Telmisartan 80mg Non-responder Trial
NCT01222520 COMPLETED PHASE3
Relative Bioavailability of Telmisartan/Amlodipine Fixed-dose Combination Compared to Its Mono-components in Healthy Male Volunteers
NCT02259803 COMPLETED PHASE1
Telmisartan, Amlodipine and Combination in Healthy Subjects
NCT01181011 COMPLETED PHASE1
To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension
NCT03021265 COMPLETED
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension
NCT06041529 RECRUITING PHASE4
Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment
NCT02620163 COMPLETED PHASE3
Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension
NCT04518293 COMPLETED PHASE3
Add-on to Micamlo BP Trial
NCT01975246 COMPLETED PHASE3
Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension
NCT00926289 COMPLETED PHASE4
The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy
NCT02231788 COMPLETED PHASE4
S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension
NCT03226340 UNKNOWN PHASE4
Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
NCT00649389 COMPLETED PHASE3
Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
NCT02526875 UNKNOWN PHASE4
Parallel-Group Comparison of Olmesartan (OLM), Amlodipine (AML) and Hydrochlorothiazid (HCTZ) in Hypertension
NCT00923091 COMPLETED PHASE3
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use
NCT01344629 COMPLETED PHASE1