Trial · NCT00624052

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

NCT00624052, Phase 3, Completed, Boehringer Ingelheim; results first posted 2010-03-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension. Trials, record NCT00624052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00624052

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in Hypertension
NCT number: NCT00624052
Status: Completed
Phases: Phase 3
Enrollment: 838 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Hypertension
Interventions: fixed-dose combination of telmisartan 40mg+amlodipine 10mg, fixed-dose combination of telmisartan 80mg+amlodipine10mg
First posted: 2008-02-26
Last updated: 2014-05-20
Results first posted: 2010-03-25

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Trough Seated Diastolic Blood Pressure (DBP) Control	End of study (34 weeks or last value on treatment)	The number of patients who reached the target DBP of \<90mmHg
Secondary	Trough Seated Systolic Blood Pressure (SBP) Control	End of study (34 weeks or last value on treatment)	The number of patients who reached the target SBP of \>=140mmHg
Secondary	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 from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6
Secondary	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)	The difference between the last available troughs represents the additional reduction in DBP in this study
Secondary	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 from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6
Secondary	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)	The difference between the last available troughs represents the additional reduction in SBP in this study
Secondary	Trough Seated DBP Response	End of study (34 weeks or last value on treatment)	The number of patients who reach the target DBP of \<90mmHg or had a reduction in DBP \>= 10mmHg
Secondary	Trough Seated SBP Response	End of study (34 weeks or last value on treatment)	The number of patients who reach the target SBP of \<140mmHg or had a reduction in SBP \>= 15 mmHg
Secondary	Trough BP Normality Classes	End of study (34 weeks or last value on treatment)	The number of patients who reach predefined BP categories
Secondary	Time to First Additional Antihypertensive	up to 34 weeks	Time from first intake of medication to first intake of an antihypertensive other than the study drug

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Trough Seated Diastolic Blood Pressure (DBP) Control	End of study (34 weeks or last value on treatment)	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	patients	NUMBER
SECONDARY	Trough Seated Systolic Blood Pressure (SBP) Control	End of study (34 weeks or last value on treatment)	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	patients	NUMBER
SECONDARY	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	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	mmHg	LEAST_SQUARES_MEAN
SECONDARY	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)	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	mmHg	LEAST_SQUARES_MEAN
SECONDARY	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	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	mmHg	LEAST_SQUARES_MEAN
SECONDARY	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)	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	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Trough Seated DBP Response	End of study (34 weeks or last value on treatment)	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	patients	NUMBER
SECONDARY	Trough Seated SBP Response	End of study (34 weeks or last value on treatment)	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	patients	NUMBER
SECONDARY	Trough BP Normality Classes	End of study (34 weeks or last value on treatment)		patients	NUMBER
SECONDARY	Time to First Additional Antihypertensive	up to 34 weeks	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	Days	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group89

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 40mg and Amlodipine 10mg	Yes (DBP<90 mmHg)	201	patients
Trough Seated Diastolic Blood Pressure (DBP) Control	Randomised Telmisartan 80mg and Amlodipine 10mg	Yes (DBP<90 mmHg)	402	patients
Trough Seated Diastolic Blood Pressure (DBP) Control	Titrated Telmisartan 80mg and Amlodipine 10mg	Yes (DBP<90 mmHg)	72	patients
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on	Yes (DBP<90 mmHg)	70	patients
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 40mg and Amlodipine 10mg	No (DBP>=90 mmHg)	15	patients
Trough Seated Diastolic Blood Pressure (DBP) Control	Randomised Telmisartan 80mg and Amlodipine 10mg	No (DBP>=90 mmHg)	34	patients
Trough Seated Diastolic Blood Pressure (DBP) Control	Titrated Telmisartan 80mg and Amlodipine 10mg	No (DBP>=90 mmHg)	19	patients
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on	No (DBP>=90 mmHg)	22	patients
Trough Seated Systolic Blood Pressure (SBP) Control	Telmisartan 40mg and Amlodipine 10mg	Yes (SBP<140 mmHg)	179	patients
Trough Seated Systolic Blood Pressure (SBP) Control	Randomised Telmisartan 80mg and Amlodipine 10mg	Yes (SBP<140 mmHg)	366	patients

1 to 10 of 89Source ClinicalTrials.gov

See all 89 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Telmisartan 40mg and Amlodipine 10mg	219
Overall Study	STARTED	Randomised Telmisartan 80mg and Amlodipine 10mg	436
Overall Study	STARTED	Titrated Telmisartan 80mg and Amlodipine 10mg	91
Overall Study	STARTED	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on	92
Overall Study	COMPLETED	Telmisartan 40mg and Amlodipine 10mg	204
Overall Study	COMPLETED	Randomised Telmisartan 80mg and Amlodipine 10mg	422
Overall Study	COMPLETED	Titrated Telmisartan 80mg and Amlodipine 10mg	88
Overall Study	COMPLETED	Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on	88
Overall Study	NOT COMPLETED	Telmisartan 40mg and Amlodipine 10mg	15
Overall Study	NOT COMPLETED	Randomised Telmisartan 80mg and Amlodipine 10mg	14

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Atrial fibrillation	Cardiac disorders	Telmisartan 40mg and Amlodipine 10mg	1	838
serious	Atrial fibrillation	Cardiac disorders	Telmisartan 80mg and Amlodipine 10mg	1	611
serious	Cardiac failure chronic	Cardiac disorders	Telmisartan 40mg and Amlodipine 10mg	0	838
serious	Cardiac failure chronic	Cardiac disorders	Telmisartan 80mg and Amlodipine 10mg	1	611
serious	Myocardial ischaemia	Cardiac disorders	Telmisartan 40mg and Amlodipine 10mg	0	838
serious	Myocardial ischaemia	Cardiac disorders	Telmisartan 80mg and Amlodipine 10mg	1	611
serious	Chest pain	General disorders	Telmisartan 40mg and Amlodipine 10mg	0	838
serious	Chest pain	General disorders	Telmisartan 80mg and Amlodipine 10mg	1	611
serious	Cholecystitis	Hepatobiliary disorders	Telmisartan 40mg and Amlodipine 10mg	0	838
serious	Cholecystitis	Hepatobiliary disorders	Telmisartan 80mg and Amlodipine 10mg	1	611

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Telmisartan 40mg and Amlodipine 10mg
Total, all-cause mortality	Telmisartan 80mg and Amlodipine 10mg
Total, other adverse events	Telmisartan 40mg and Amlodipine 10mg	0	838
Total, other adverse events	Telmisartan 80mg and Amlodipine 10mg	0	611
Total, serious adverse events	Telmisartan 40mg and Amlodipine 10mg	4	838
Total, serious adverse events	Telmisartan 80mg and Amlodipine 10mg	13	611

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24653513	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Telmisartan 40mg and Amlodipine 10mg vs Telmisartan 80mg and Amlodipine 10mg: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00624052

GET https://conductscience.org/api/trials/v1/NCT00624052/results?page=2

API reference For AI assistants