Clinical trial NCT00624052: 26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 838
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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).


Eligibility 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 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.

Primary outcomes:
measure: Trough Seated Diastolic Blood Pressure (DBP) Control
timeFrame: End of study (34 weeks or last value on treatment)
Secondary outcomes:
measure: Trough Seated Systolic Blood Pressure (SBP) Control
timeFrame: End of study (34 weeks or last value on treatment)
measure: Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure
timeFrame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
measure: Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
timeFrame: Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)
measure: Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure
timeFrame: Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
measure: Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
timeFrame: Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)
measure: Trough Seated DBP Response
timeFrame: End of study (34 weeks or last value on treatment)
measure: Trough Seated SBP Response
timeFrame: End of study (34 weeks or last value on treatment)
measure: Trough BP Normality Classes
timeFrame: End of study (34 weeks or last value on treatment)
measure: Time to First Additional Antihypertensive
timeFrame: up to 34 weeks
measure: Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
timeFrame: up to 34 weeks
measure: Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
timeFrame: up to 34 weeks
measure: Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
timeFrame: up to 34 weeks
measure: Trough DBP Control Pre- and Post- Uptitration
timeFrame: up to 34 weeks
Other outcomes:
Locations:
city: Gosford
country: Australia
facility: 1235.8.61003 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Liverpool
country: Australia
facility: 1235.8.61004 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Kippa-Ring
country: Australia
facility: 1235.8.61002 Boehringer Ingelheim Investigational Site
state: Queensland
city: Milton
country: Australia
facility: 1235.8.61001 Boehringer Ingelheim Investigational Site
state: Queensland
city: Elizabeth Vale
country: Australia
facility: 1235.8.61005 Boehringer Ingelheim Investigational Site
state: South Australia
city: Eggenburg
country: Austria
facility: 1235.8.43007 Boehringer Ingelheim Investigational Site
city: Hainburg a.d. Donau
country: Austria
facility: 1235.8.43006 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1235.8.43001 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1235.8.43002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1235.8.43003 Boehringer Ingelheim Investigational Site
city: Bourgas
country: Bulgaria
facility: 1235.8.35912 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.8.35902 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.8.35903 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.8.35904 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.8.35905 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.8.35906 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.8.35907 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.8.35910 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1235.8.35911 Boehringer Ingelheim Investigational Site
city: Benatky nad Jizerou
country: Czech Republic
facility: 1235.8.42002 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1235.8.42006 Boehringer Ingelheim Investigational Site
city: Plzen
country: Czech Republic
facility: 1235.8.42001 Boehringer Ingelheim Investigational Site
city: Praha 5
country: Czech Republic
facility: 1235.8.42003 Boehringer Ingelheim Investigational Site
city: Pribram
country: Czech Republic
facility: 1235.8.42004 Boehringer Ingelheim Investigational Site
city: Slany
country: Czech Republic
facility: 1235.8.42005 Boehringer Ingelheim Investigational Site
city: Strakonice
country: Czech Republic
facility: 1235.8.42007 Boehringer Ingelheim Investigational Site
city: Birr
country: Ireland
facility: 1235.8.35304 Boehringer Ingelheim Investigational Site
city: Carrigtowhill
country: Ireland
facility: 1235.8.35305 Boehringer Ingelheim Investigational Site
city: Gorey, Co. Wexford
country: Ireland
facility: 1235.8.35303 Boehringer Ingelheim Investigational Site
city: Mallow
country: Ireland
facility: 1235.8.35306 Boehringer Ingelheim Investigational Site
city: New Ross
country: Ireland
facility: 1235.8.35301 Boehringer Ingelheim Investigational Site
city: Broni (pv)
country: Italy
facility: 1235.8.39002 Boehringer Ingelheim Investigational Site
city: Coppito (AQ)
country: Italy
facility: 1235.8.39006 Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: 1235.8.39001 Boehringer Ingelheim Investigational Site
city: Dunedin
country: New Zealand
facility: 1235.8.64003 Boehringer Ingelheim Investigational Site
city: Otahuhu, Auckland
country: New Zealand
facility: 1235.8.64002 Boehringer Ingelheim Investigational Site
city: Tauranga
country: New Zealand
facility: 1235.8.64001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.8.70004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.8.70005 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.8.70006 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.8.70007 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.8.70008 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1235.8.70009 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.8.70010 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.8.70011 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1235.8.70012 Boehringer Ingelheim Investigational Site
city: Dolny Kubin
country: Slovakia
facility: 1235.8.42103 Boehringer Ingelheim Investigational Site
city: Kralovsky Chmlec
country: Slovakia
facility: 1235.8.42106 Boehringer Ingelheim Investigational Site
city: Liptovsky Mikulas
country: Slovakia
facility: 1235.8.42104 Boehringer Ingelheim Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: 1235.8.42102 Boehringer Ingelheim Investigational Site
city: Presov
country: Slovakia
facility: 1235.8.42105 Boehringer Ingelheim Investigational Site
city: Trencin
country: Slovakia
facility: 1235.8.42101 Boehringer Ingelheim Investigational Site
city: Vrable
country: Slovakia
facility: 1235.8.42107 Boehringer Ingelheim Investigational Site
city: Badalona
country: Spain
facility: 1235.8.34008 Boehringer Ingelheim Investigational Site
city: Badalona
country: Spain
facility: 1235.8.34010 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1235.8.34009 Boehringer Ingelheim Investigational Site
city: Jerez de la Frontera (Cádiz)
country: Spain
facility: 1235.8.34001 Boehringer Ingelheim Investigational Site
city: L'Hospitalet de Llobregat (Barcelona)
country: Spain
facility: 1235.8.34006 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1235.8.34003 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1235.8.34004 Boehringer Ingelheim Investigational Site
city: Mataró
country: Spain
facility: 1235.8.34012 Boehringer Ingelheim Investigational Site
city: Oviedo
country: Spain
facility: 1235.8.34002 Boehringer Ingelheim Investigational Site
city: Santa Coloma de Gramanet
country: Spain
facility: 1235.8.34005 Boehringer Ingelheim Investigational Site
city: Santa Coloma de Gramanet
country: Spain
facility: 1235.8.34011 Boehringer Ingelheim Investigational Site
city: Dnepropetrovsk
country: Ukraine
facility: 1235.8.38010 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.8.38001 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.8.38003 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.8.38008 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1235.8.38011 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.8.38004 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.8.38006 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.8.38012 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1235.8.38013 Boehringer Ingelheim Investigational Site
city: Lvov
country: Ukraine
facility: 1235.8.38002 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1235.8.38005 Boehringer Ingelheim Investigational Site
city: Odessa
country: Ukraine
facility: 1235.8.38009 Boehringer Ingelheim Investigational Site
city: Zaporozhye
country: Ukraine
facility: 1235.8.38007 Boehringer Ingelheim Investigational Site
city: Bexhill on Sea
country: United Kingdom
facility: 1235.8.44010 Boehringer Ingelheim Investigational Site
city: Blackpool
country: United Kingdom
facility: 1235.8.44008 Boehringer Ingelheim Investigational Site
city: Blackpool
country: United Kingdom
facility: 1235.8.44016 Boehringer Ingelheim Investigational Site
city: Burbage
country: United Kingdom
facility: 1235.8.44011 Boehringer Ingelheim Investigational Site
city: Chestfield, Whitstable
country: United Kingdom
facility: 1235.8.44007 Boehringer Ingelheim Investigational Site
city: Chorley
country: United Kingdom
facility: 1235.8.44005 Boehringer Ingelheim Investigational Site
city: Edgbaston, Birmingham
country: United Kingdom
facility: 1235.8.44002 Boehringer Ingelheim Investigational Site
city: Ely
country: United Kingdom
facility: 1235.8.44009 Boehringer Ingelheim Investigational Site
city: Fowey
country: United Kingdom
facility: 1235.8.44001 Boehringer Ingelheim Investigational Site
city: Glasgow
country: United Kingdom
facility: 1235.8.44003 Boehringer Ingelheim Investigational Site
city: Penzance
country: United Kingdom
facility: 1235.8.44012 Boehringer Ingelheim Investigational Site
city: Plymouth
country: United Kingdom
facility: 1235.8.44013 Boehringer Ingelheim Investigational Site
city: Reading
country: United Kingdom
facility: 1235.8.44004 Boehringer Ingelheim Investigational Site
city: St. Austell
country: United Kingdom
facility: 1235.8.44015 Boehringer Ingelheim Investigational Site
city: Whitstable
country: United Kingdom
facility: 1235.8.44006 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.