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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00624052




Registration number
NCT00624052
Ethics application status
Date submitted
5/02/2008
Date registered
26/02/2008
Date last updated
20/05/2014

Titles & IDs
Public title
26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
Scientific 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
Secondary ID [1] 0 0
1235.8
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - fixed-dose combination of telmisartan 40mg+amlodipine 10mg
Treatment: Drugs - fixed-dose combination of telmisartan 80mg+amlodipine10mg

Treatment: Drugs: fixed-dose combination of telmisartan 40mg+amlodipine 10mg


Treatment: Drugs: fixed-dose combination of telmisartan 80mg+amlodipine10mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trough Seated Diastolic Blood Pressure (DBP) Control
Timepoint [1] 0 0
End of study (34 weeks or last value on treatment)
Secondary outcome [1] 0 0
Trough Seated Systolic Blood Pressure (SBP) Control
Timepoint [1] 0 0
End of study (34 weeks or last value on treatment)
Secondary outcome [2] 0 0
Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure
Timepoint [2] 0 0
Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Secondary outcome [3] 0 0
Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Timepoint [3] 0 0
Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)
Secondary outcome [4] 0 0
Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure
Timepoint [4] 0 0
Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Secondary outcome [5] 0 0
Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Timepoint [5] 0 0
Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)
Secondary outcome [6] 0 0
Trough Seated DBP Response
Timepoint [6] 0 0
End of study (34 weeks or last value on treatment)
Secondary outcome [7] 0 0
Trough Seated SBP Response
Timepoint [7] 0 0
End of study (34 weeks or last value on treatment)
Secondary outcome [8] 0 0
Trough BP Normality Classes
Timepoint [8] 0 0
End of study (34 weeks or last value on treatment)
Secondary outcome [9] 0 0
Time to First Additional Antihypertensive
Timepoint [9] 0 0
up to 34 weeks
Secondary outcome [10] 0 0
Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Timepoint [10] 0 0
up to 34 weeks
Secondary outcome [11] 0 0
Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Timepoint [11] 0 0
up to 34 weeks
Secondary outcome [12] 0 0
Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Timepoint [12] 0 0
up to 34 weeks
Secondary outcome [13] 0 0
Trough DBP Control Pre- and Post- Uptitration
Timepoint [13] 0 0
up to 34 weeks

Eligibility
Key inclusion criteria
- diagnosis of essential hypertension
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
838
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
1235.8.61003 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [2] 0 0
1235.8.61004 Boehringer Ingelheim Investigational Site - Liverpool
Recruitment hospital [3] 0 0
1235.8.61002 Boehringer Ingelheim Investigational Site - Kippa-Ring
Recruitment hospital [4] 0 0
1235.8.61001 Boehringer Ingelheim Investigational Site - Milton
Recruitment hospital [5] 0 0
1235.8.61005 Boehringer Ingelheim Investigational Site - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Kippa-Ring
Recruitment postcode(s) [4] 0 0
- Milton
Recruitment postcode(s) [5] 0 0
- Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Eggenburg
Country [2] 0 0
Austria
State/province [2] 0 0
Hainburg a.d. Donau
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Bourgas
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Benatky nad Jizerou
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Brno
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Plzen
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Praha 5
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Pribram
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Slany
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Strakonice
Country [13] 0 0
Ireland
State/province [13] 0 0
Birr
Country [14] 0 0
Ireland
State/province [14] 0 0
Carrigtowhill
Country [15] 0 0
Ireland
State/province [15] 0 0
Gorey, Co. Wexford
Country [16] 0 0
Ireland
State/province [16] 0 0
Mallow
Country [17] 0 0
Ireland
State/province [17] 0 0
New Ross
Country [18] 0 0
Italy
State/province [18] 0 0
Broni (pv)
Country [19] 0 0
Italy
State/province [19] 0 0
Coppito (AQ)
Country [20] 0 0
Italy
State/province [20] 0 0
Ferrara
Country [21] 0 0
New Zealand
State/province [21] 0 0
Dunedin
Country [22] 0 0
New Zealand
State/province [22] 0 0
Otahuhu, Auckland
Country [23] 0 0
New Zealand
State/province [23] 0 0
Tauranga
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Moscow
Country [25] 0 0
Russian Federation
State/province [25] 0 0
St. Petersburg
Country [26] 0 0
Slovakia
State/province [26] 0 0
Dolny Kubin
Country [27] 0 0
Slovakia
State/province [27] 0 0
Kralovsky Chmlec
Country [28] 0 0
Slovakia
State/province [28] 0 0
Liptovsky Mikulas
Country [29] 0 0
Slovakia
State/province [29] 0 0
Povazska Bystrica
Country [30] 0 0
Slovakia
State/province [30] 0 0
Presov
Country [31] 0 0
Slovakia
State/province [31] 0 0
Trencin
Country [32] 0 0
Slovakia
State/province [32] 0 0
Vrable
Country [33] 0 0
Spain
State/province [33] 0 0
Badalona
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Jerez de la Frontera (Cádiz)
Country [36] 0 0
Spain
State/province [36] 0 0
L'Hospitalet de Llobregat (Barcelona)
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Mataró
Country [39] 0 0
Spain
State/province [39] 0 0
Oviedo
Country [40] 0 0
Spain
State/province [40] 0 0
Santa Coloma de Gramanet
Country [41] 0 0
Ukraine
State/province [41] 0 0
Dnepropetrovsk
Country [42] 0 0
Ukraine
State/province [42] 0 0
Kharkov
Country [43] 0 0
Ukraine
State/province [43] 0 0
Kiev
Country [44] 0 0
Ukraine
State/province [44] 0 0
Lvov
Country [45] 0 0
Ukraine
State/province [45] 0 0
Odessa
Country [46] 0 0
Ukraine
State/province [46] 0 0
Zaporozhye
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Bexhill on Sea
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Blackpool
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Burbage
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Chestfield, Whitstable
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Chorley
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Edgbaston, Birmingham
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Ely
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Fowey
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Glasgow
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Penzance
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Plymouth
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Reading
Country [59] 0 0
United Kingdom
State/province [59] 0 0
St. Austell
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Whitstable

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00624052
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries