26-week Open Study of telmisartan40mg+amlodipine10mg or t... | NCT00624052

NCT00624052

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Trough Seated Systolic Blood Pressure (SBP) Control	The number of patients who reached the target SBP of >=140mmHg	End of study (34 weeks or last value on treatment)
Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure

Eligibility Module

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.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1235.8.61003 Boehringer Ingelheim Investigational Site		Gosford	New South Wales		Australia
1235.8.61004 Boehringer Ingelheim Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24653513	Derived	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.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Telmisartan 40mg and Amlodipine 10mg	Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit
FG001	Randomised Telmisartan 80mg and Amlodipine 10mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Trough Seated Diastolic Blood Pressure (DBP) Control

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

The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Posted

Number

patients

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

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants	OG000216 OG001436 OG00291 OG003

Title

Denominators

Categories

Yes (DBP<90 mmHg)

Title	Measurements
	OG000201 OG001402 OG00272 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel				Odds Ratio (OR)	0.88				95	0.47	1.66				No	Superiority or Other
OG000 OG002		Cochran-Mantel-Haenszel

Secondary

Trough Seated Systolic Blood Pressure (SBP) Control

The number of patients who reached the target SBP of >=140mmHg

The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Posted

Number

patients

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

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants	OG000

Secondary

Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure

Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6

All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose

Posted

Least Squares Mean

Standard Error

mmHg

Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants

Secondary

Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052

The difference between the last available troughs represents the additional reduction in DBP in this study

All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose

Posted

Least Squares Mean

Standard Error

mmHg

Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants

Secondary

Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure

Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6

All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose

Posted

Least Squares Mean

Standard Error

mmHg

Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants

Secondary

Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052

The difference between the last available troughs represents the additional reduction in SBP in this study

All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose

Posted

Least Squares Mean

Standard Error

mmHg

Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants

Secondary

Trough Seated DBP Response

The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg

All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose

Posted

Number

patients

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

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants

Secondary

Trough Seated SBP Response

The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg

All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose

Posted

Number

patients

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

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants

Secondary

Trough BP Normality Classes

The number of patients who reach predefined BP categories

Posted

Number

patients

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

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg
OG001	Randomised Telmisartan 80mg and Amlodipine 10mg
OG002	Titrated Telmisartan 80mg and Amlodipine 10mg
OG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on

Units	Counts
Participants	OG000

Secondary

Time to First Additional Antihypertensive

Time from first intake of medication to first intake of an antihypertensive other than the study drug

The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

Posted

Mean

Standard Deviation

Days

up to 34 weeks

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg

Units	Counts
Participants	OG000121

Secondary

Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control

The number of patients with DBP control (DBP>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment

Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

Posted

Number

patients

up to 34 weeks

ID	Title	Description
OG000	Pre-antihypertensive: Yes (DBP<90 mmHg)
OG001	Pre-antihypertensive: No (DBP>=90 mmHg)
OG002	Pre-antihypertensive: Total

Units	Counts
Participants	OG000

Secondary

Additional Reduction in DBP by Use of Additional Antihypertensive Therapy

Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052

Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment

Posted

Mean

Standard Deviation

mmHg

up to 34 weeks

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg

Units	Counts
Participants	OG000121

Secondary

Additional Reduction in SBP by Use of Additional Antihypertensive Therapy

Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052

Total for the full analysis set

Posted

Mean

Standard Deviation

mmHg

up to 34 weeks

ID	Title	Description
OG000	Telmisartan 40mg and Amlodipine 10mg

Units	Counts
Participants	OG000121

Title	Denominators

Secondary

Trough DBP Control Pre- and Post- Uptitration

The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.

91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.

Posted

Number

patients

up to 34 weeks

ID	Title	Description
OG000	Pre-titration: Yes (DBP<90 mmHg)
OG001	Pre-titration: No (DBP>=90 mmHg)
OG002	Pre-titration: Total

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Telmisartan 40mg and Amlodipine 10mg	The 838 participants in the telmisartan 40mg/amlodipine 10mg group includes all participants			4	838	0	838
EG001	Telmisartan 80mg and Amlodipine 10mg	The 611 participants in the telmisartan 80mg/amlodipine 10mg (T80/A10) group include 436 patients in the randomised T80/A10 group + 91 patients in the uptitrated T80/A10 group + XX patients in the T80/A10 + add-on group			13	611	0	611

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	12.0	Systematic Assessment	EG0001 affected838 at risk EG0011 affected611 at risk
Cardiac failure chronic	Cardiac disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Myocardial ischaemia	Cardiac disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Chest pain	General disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Cholecystitis	Hepatobiliary disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Pulmonary tuberculosis	Infections and infestations	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Stent related infection	Infections and infestations	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Vestibular neuronitis	Infections and infestations	12.0	Systematic Assessment	EG0001 affected838 at risk EG0010 affected611 at risk
Ankle fracture	Injury, poisoning and procedural complications	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Fall	Injury, poisoning and procedural complications	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Postoperative fever	Injury, poisoning and procedural complications	12.0	Systematic Assessment	EG0001 affected838 at risk EG0010 affected611 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Fibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	12.0	Systematic Assessment	EG0001 affected838 at risk EG0010 affected611 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Calculus ureteric	Renal and urinary disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	12.0	Systematic Assessment	EG0001 affected838 at risk EG0010 affected611 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	12.0	Systematic Assessment	EG0001 affected838 at risk EG0011 affected611 at risk
Parasoriasis	Skin and subcutaneous tissue disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Aortic dissection	Vascular disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0011 affected611 at risk
Hypertensive crisis	Vascular disorders	12.0	Systematic Assessment	EG0000 affected838 at risk EG0012 affected611 at risk

Name	Type	Description	Arm Group Labels	Other Names
fixed-dose combination of telmisartan 40mg+amlodipine 10mg	Drug
fixed-dose combination of telmisartan 80mg+amlodipine10mg	Drug

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Telmisartan 40mg and Amlodipine 10mg
BG001	Randomised Telmisartan 80mg and Amlodipine 10mg
BG002	Titrated Telmisartan 80mg and Amlodipine 10mg
BG003	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
BG004	Total	Total of all reporting groups