An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618774

Enrollment

259

Registered

2008-02-20

Start date

2008-01-31

Completion date

Unknown

Last updated

2014-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy

Interventions

DRUGtelmisartan40/amlodipine5

DRUGtelmisartan80/amlodipine5

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with essential hypertension 2. Outpatient

Exclusion criteria

* Patients whose SBP \>=180 mmHg or DBP \>=110 mmHg at the end of treatment visit of the double-blind treatment period in the non-responder trials * Patients who have met any of the

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Experienced Adverse Events	52 weeks	An adverse event is defined as any untoward medical occurrence
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	First administration of study treatment to 24 hours post last dosing of study treatment.	Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.

Secondary

Measure	Time frame	Description
Seated DBP Control Rate at Trough After 8 Weeks	week 8	Percentage of patients whose DBP \<90 mmHg after 8 weeks of treatment
Seated SBP Control Rate at Trough After 8 Weeks	Week 8	Percentage of patients whose SBP \<140 mmHg after 8 weeks of treatment
Change From Baseline in Seated Diastolic Blood Pressure	Baseline and week 20 / week 48	Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Change From Baseline in Seated Systolic Blood Pressure	Baseline and week 20 / week 48	mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Change From Baseline in Seated Diastolic Blood Pressure at Week 8	Baseline and week 8	mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Seated SBP Control Rate at Trough After 6 and 12 Months	6 months and 12 months	Percentage of patients whose SBP \<140 mmHg
Seated DBP Response Rate at Trough	6 months and 12 months	Percentage of patients whose DBP \<90 mmHg or decreased from pseudo-baseline by \>=10 mmHg at 6 months and 12 months
Seated SBP Response Rate at Trough	6 months and 12 months	Percentage of patients whose SBP \<140 mmHg or decreased deom pseudo-baseline by \>=20 mmHg after 6 and 12 months
Seated Blood Pressure Normalisation at Trough	6 months and 12 months	Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months: Optimal: SBP \<120 mmHg and DBP \<80 mmHg Normal: SBP \>=120 mmHg or DBP \>=80 mmHg and SBP \<130 mmHg or DBP \<85 mmHg High normal: SBP \>=130 mmHg or DBP \>=85 mmHg and SBP \<140 mmHg or DBP \<90 mmHg No: SBP \>=140 mmHg or DBP \>=90 mmHg
Seated DBP Control Rate at Trough After 6 and 12 Months	6 months and 12 months	Percentage of patients whose DBP \<90 mmHg.
Change From Baseline in Seated Systolic Blood Pressure at Week 8	Baseline and week 8	mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure

Countries

Japan

Participant flow

Participants by arm

Arm	Count
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	211
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	48
Total	259

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	5	3
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Total
Age, Continuous	56.8 Years STANDARD_DEVIATION 9	51.1 Years STANDARD_DEVIATION 8	55.8 Years STANDARD_DEVIATION 9
Sex: Female, Male Female	50 Participants	4 Participants	54 Participants
Sex: Female, Male Male	161 Participants	44 Participants	205 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	102 / 211	23 / 48
serious Total, serious adverse events	9 / 211	3 / 48

Outcome results

Primary

Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG

Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.

Time frame: First administration of study treatment to 24 hours post last dosing of study treatment.

Population: Treated set

Arm	Measure	Group	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Atrial fibrillation	2 participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Acute myocardial infarction	0 participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Extrasystoles	1 participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Blood Pressure Decreased	2 participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Ventricular extrasystoles	1 participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Arrhythmia	1 participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Orthostatic hypotension	0 participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Prostatic specific antigen increased	1 participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Orthostatic hypotension	1 participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Prostatic specific antigen increased	0 participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Acute myocardial infarction	1 participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Arrhythmia	0 participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Atrial fibrillation	0 participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Extrasystoles	0 participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Ventricular extrasystoles	0 participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG	Blood Pressure Decreased	0 participants

Primary

Percentage of Participants Who Experienced Adverse Events

An adverse event is defined as any untoward medical occurrence

Time frame: 52 weeks

Population: Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.

Arm	Measure	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Percentage of Participants Who Experienced Adverse Events	77.3 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Percentage of Participants Who Experienced Adverse Events	77.1 percentage of participants

Secondary

Change From Baseline in Seated Diastolic Blood Pressure

Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure

Time frame: Baseline and week 20 / week 48

Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.

Arm	Measure	Group	Value (MEAN)	Dispersion
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Diastolic Blood Pressure	Week 20	20.67 mmHg	Standard Deviation 7.16
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Diastolic Blood Pressure	Week 48	21.39 mmHg	Standard Deviation 6.6
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Diastolic Blood Pressure	Week 20	16.36 mmHg	Standard Deviation 5.93
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Diastolic Blood Pressure	Week 48	17.78 mmHg	Standard Deviation 7.31

Secondary

Change From Baseline in Seated Diastolic Blood Pressure at Week 8

mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure

Time frame: Baseline and week 8

Arm	Measure	Value (MEAN)	Dispersion
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Diastolic Blood Pressure at Week 8	20.81 mmHg	Standard Deviation 6.65
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Diastolic Blood Pressure at Week 8	15.75 mmHg	Standard Deviation 6.61

Secondary

Change From Baseline in Seated Systolic Blood Pressure

mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure

Time frame: Baseline and week 20 / week 48

Arm	Measure	Group	Value (MEAN)	Dispersion
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Systolic Blood Pressure	Week 20	33.73 mmHg	Standard Deviation 12.55
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Systolic Blood Pressure	Week 48	33.97 mmHg	Standard Deviation 11.75
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Systolic Blood Pressure	Week 20	27.18 mmHg	Standard Deviation 11.83
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Systolic Blood Pressure	Week 48	28.11 mmHg	Standard Deviation 12.78

Secondary

Change From Baseline in Seated Systolic Blood Pressure at Week 8

mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure

Time frame: Baseline and week 8

Arm	Measure	Value (MEAN)	Dispersion
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Systolic Blood Pressure at Week 8	33.89 mmHg	Standard Deviation 12.2
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Change From Baseline in Seated Systolic Blood Pressure at Week 8	26.44 mmHg	Standard Deviation 11.68

Secondary

Seated Blood Pressure Normalisation at Trough

Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months: Optimal: SBP \<120 mmHg and DBP \<80 mmHg Normal: SBP \>=120 mmHg or DBP \>=80 mmHg and SBP \<130 mmHg or DBP \<85 mmHg High normal: SBP \>=130 mmHg or DBP \>=85 mmHg and SBP \<140 mmHg or DBP \<90 mmHg No: SBP \>=140 mmHg or DBP \>=90 mmHg

Time frame: 6 months and 12 months

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 20: Optimal	29.5 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 20: Normal	35.3 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 20: High Normal	24.2 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 20: No	11.1 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 48: Optimal	32.4 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 48: Normal	36.2 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 48: High Normal	18.4 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 48: No	13.0 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 48: No	35.4 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 20: Optimal	4.2 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 48: Optimal	6.3 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 20: Normal	18.8 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 48: High Normal	39.6 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 20: High Normal	31.3 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 48: Normal	18.8 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated Blood Pressure Normalisation at Trough	Week 20: No	45.8 percentage of participants

Secondary

Seated DBP Control Rate at Trough After 6 and 12 Months

Percentage of patients whose DBP \<90 mmHg.

Time frame: 6 months and 12 months

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Control Rate at Trough After 6 and 12 Months	Week 20	90.8 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Control Rate at Trough After 6 and 12 Months	Week 48	92.8 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Control Rate at Trough After 6 and 12 Months	Week 20	54.2 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Control Rate at Trough After 6 and 12 Months	Week 48	66.7 percentage of participants

Secondary

Seated DBP Control Rate at Trough After 8 Weeks

Percentage of patients whose DBP \<90 mmHg after 8 weeks of treatment

Time frame: week 8

Population: FAS

Arm	Measure	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Control Rate at Trough After 8 Weeks	91.8 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Control Rate at Trough After 8 Weeks	52.1 percentage of participants

Secondary

Seated DBP Response Rate at Trough

Percentage of patients whose DBP \<90 mmHg or decreased from pseudo-baseline by \>=10 mmHg at 6 months and 12 months

Time frame: 6 months and 12 months

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Response Rate at Trough	Week 20	97.1 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Response Rate at Trough	Week 48	98.6 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Response Rate at Trough	Week 48	87.5 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated DBP Response Rate at Trough	Week 20	85.4 percentage of participants

Secondary

Seated SBP Control Rate at Trough After 6 and 12 Months

Percentage of patients whose SBP \<140 mmHg

Time frame: 6 months and 12 months

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Control Rate at Trough After 6 and 12 Months	Week 20	95.7 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Control Rate at Trough After 6 and 12 Months	Week 48	93.2 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Control Rate at Trough After 6 and 12 Months	Week 20	89.6 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Control Rate at Trough After 6 and 12 Months	Week 48	89.6 percentage of participants

Secondary

Seated SBP Control Rate at Trough After 8 Weeks

Percentage of patients whose SBP \<140 mmHg after 8 weeks of treatment

Time frame: Week 8

Population: FAS

Arm	Measure	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Control Rate at Trough After 8 Weeks	93.2 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Control Rate at Trough After 8 Weeks	85.4 percentage of participants

Secondary

Seated SBP Response Rate at Trough

Percentage of patients whose SBP \<140 mmHg or decreased deom pseudo-baseline by \>=20 mmHg after 6 and 12 months

Time frame: 6 months and 12 months

Population: FAS

Arm	Measure	Group	Value (NUMBER)
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Response Rate at Trough	Week 20	97.6 percentage of participants
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Response Rate at Trough	Week 48	97.6 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Response Rate at Trough	Week 20	93.8 percentage of participants
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination	Seated SBP Response Rate at Trough	Week 48	93.8 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG

Percentage of Participants Who Experienced Adverse Events

Change From Baseline in Seated Diastolic Blood Pressure

Change From Baseline in Seated Diastolic Blood Pressure at Week 8

Change From Baseline in Seated Systolic Blood Pressure

Change From Baseline in Seated Systolic Blood Pressure at Week 8

Seated Blood Pressure Normalisation at Trough

Seated DBP Control Rate at Trough After 6 and 12 Months

Seated DBP Control Rate at Trough After 8 Weeks

Seated DBP Response Rate at Trough

Seated SBP Control Rate at Trough After 6 and 12 Months

Seated SBP Control Rate at Trough After 8 Weeks

Seated SBP Response Rate at Trough