Trial · NCT00614380

Open Label Study Telmisartan and Amlodipine in Hypertension

NCT00614380, Phase 3, Completed, Boehringer Ingelheim; results first posted 2010-01-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open Label Study Telmisartan and Amlodipine in Hypertension. Trials, record NCT00614380. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00614380

On this page

Trial

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

Title: Open Label Study Telmisartan and Amlodipine in Hypertension
NCT number: NCT00614380
Status: Completed
Phases: Phase 3
Enrollment: 976 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Hypertension
Interventions: telmisartan/amlodipine 40/5 mg fixed combination, telmisartan/amlodipine 80/5 mg fixed combination
First posted: 2008-02-13
Last updated: 2014-02-13
Other registries' IDs: eudract:2007-002410-19
Results first posted: 2010-01-18

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 reach 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 reach the target SBP of \<140mmHg
Secondary	Change From Baseline in Trough Seated Diastolic Blood Pressure	End of study (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 1235.5.
Secondary	Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7	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 in Trough Seated Systolic Blood Pressure	End of study (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 1235.5.
Secondary	Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7	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 Blood Pressure (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	At any point during open-label treatment	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	Participants	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	Participants	NUMBER
SECONDARY	Change From Baseline in Trough Seated Diastolic Blood Pressure	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 1235.5) 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 1235.5 to Last Available Trough in 1235.7	End of study (34 weeks or last value on treatment)	Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Trough Seated Systolic Blood Pressure	End of study (34 weeks or last value on treatment)	Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement	mmHg	LEAST_SQUARES_MEAN
SECONDARY	Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7	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 (Last value on treatment in 1235.5) 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)	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	Participants	NUMBER
SECONDARY	Trough Seated SBP Response	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	Participants	NUMBER
SECONDARY	Trough Blood Pressure (BP) Normality Classes	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	Participants	NUMBER
SECONDARY	Time to First Additional Antihypertensive	At any point during open-label treatment	Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as 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	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 5mg	Yes (DBP<90 mmHg)	504	Participants
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 80mg and Amlodipine 5mg	Yes (DBP<90 mmHg)	160	Participants
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Yes (DBP<90 mmHg)	19	Participants
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	Yes (DBP<90 mmHg)	84	Participants
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 40mg and Amlodipine 5mg	No (DBP>=90 mmHg)	49	Participants
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 80mg and Amlodipine 5mg	No (DBP>=90 mmHg)	46	Participants
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	No (DBP>=90 mmHg)	6	Participants
Trough Seated Diastolic Blood Pressure (DBP) Control	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	No (DBP>=90 mmHg)	97	Participants
Trough Seated Systolic Blood Pressure (SBP) Control	Telmisartan 40mg and Amlodipine 5mg	Yes (SBP<140 mmHg)	440	Participants
Trough Seated Systolic Blood Pressure (SBP) Control	Telmisartan 80mg and Amlodipine 5mg	Yes (SBP<140 mmHg)	142	Participants

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 5mg	564
Overall Study	STARTED	Telmisartan 80mg and Amlodipine 5mg	206
Overall Study	STARTED	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	25
Overall Study	STARTED	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	181
Overall Study	COMPLETED	Telmisartan 40mg and Amlodipine 5mg	529
Overall Study	COMPLETED	Telmisartan 80mg and Amlodipine 5mg	198
Overall Study	COMPLETED	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	24
Overall Study	COMPLETED	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	179
Overall Study	NOT COMPLETED	Telmisartan 40mg and Amlodipine 5mg	35
Overall Study	NOT COMPLETED	Telmisartan 80mg and Amlodipine 5mg	8

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events66

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
other	Oedema peripheral	General disorders	Telmisartan 40mg and Amlodipine 5mg	32	976
other	Oedema peripheral	General disorders	Telmisartan 80mg and Amlodipine 5mg	21	397
other	Back pain	Musculoskeletal and connective tissue disorders	Telmisartan 40mg and Amlodipine 5mg	25	976
other	Back pain	Musculoskeletal and connective tissue disorders	Telmisartan 80mg and Amlodipine 5mg	24	397
serious	Acute myocardial infarction	Cardiac disorders	Telmisartan 40mg and Amlodipine 5mg	1	976
serious	Acute myocardial infarction	Cardiac disorders	Telmisartan 80mg and Amlodipine 5mg	1	397
serious	Atrial fibrillation	Cardiac disorders	Telmisartan 40mg and Amlodipine 5mg	1	976
serious	Atrial fibrillation	Cardiac disorders	Telmisartan 80mg and Amlodipine 5mg	0	397
serious	Cardiac failure	Cardiac disorders	Telmisartan 40mg and Amlodipine 5mg	0	976
serious	Cardiac failure	Cardiac disorders	Telmisartan 80mg and Amlodipine 5mg	1	397

1 to 10 of 66Source ClinicalTrials.gov

See all 66 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 5mg
Total, all-cause mortality	Telmisartan 80mg and Amlodipine 5mg
Total, other adverse events	Telmisartan 40mg and Amlodipine 5mg	57	976
Total, other adverse events	Telmisartan 80mg and Amlodipine 5mg	45	397
Total, serious adverse events	Telmisartan 40mg and Amlodipine 5mg	22	976
Total, serious adverse events	Telmisartan 80mg and Amlodipine 5mg	6	397

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 5mg vs Telmisartan 80mg and Amlodipine 5mg: 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.

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