Comparison in Japan T80/A5 (Telmisartan 80 mg and Amlodipine 5 mg) and T40/A5 (Telmisartan 40 mg and Amlodipine 5 mg)

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01286558
• Collaborator: (none)
• Enrollment: 225
• Locations: 8
• Arms: 2
• Patients Per Site: 28.1

Study Details

Study Description

Brief Summary

Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone, often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect. Therefore in Japanese Society of Hypertension (JSH) 2009 combination therapy is recommended. In JSH 2009 it is advised to start the combination therapy at a low dose, and to increase the dosage when the antihypertensive effect is not sufficient. In the Japanese long-term safety study, 259 patients received the T40/A5 mg fixed-dose combination (FDC), and after 6 weeks treatment 48 patients of them could not control their blood pressure (DBP =90) (U09-2494-01). For those patients who cannot control their blood pressure with T40/A5 mg FDC, a switch to a higher dose such as T80/A5 mg is recommended.

In the overseas 4x4 factorial design trial, a clinically meaningful difference of the blood pressure lowering effect between T80/A5 mg free combination and T40/A5 mg free combination was shown (U07-3503-02). But the sponsor has no data that verifies this difference in Japanese patients.

Thus, this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80/A5 mg FDC compared with low dose T40/A5 mg FDC in Japanese patients with essential hypertension. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: 40 mg telmisartan; Drug: 5 mg amlodipine; Drug: 5 mg amlodipine; Drug: 80 mg telmisartan	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg Plus Amlodipine 5 mg Fixed-dose Combination vs. Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination in Patients With Hypertension
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 80mg telmisartan and 5mg amlodipine FDC once daily	Drug: 5 mg amlodipine; once daily; Drug: 80 mg telmisartan; once daily
Active Comparator: 40mg telmisartan and 5mg amlodipine FDC once daily	Drug: 40 mg telmisartan; once daily; Drug: 5 mg amlodipine; once daily

Outcome Measures

Primary Outcome Measures

1. Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough [Reference baseline, 8 weeks]

   Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

Secondary Outcome Measures

1. Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough [Reference baseline, 8 weeks]

   Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing

2. Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP [Reference baseline, 8 weeks]

   Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined

3. Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP [Reference baseline, 8 weeks]

   Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined

4. Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP [Pseudo-baseline, 14 weeks]

   Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined

5. Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP [Pseudo-baseline, 14 weeks]

   Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined

6. Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM [Reference baseline, 8 weeks]

   Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined

7. Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM [Reference baseline, 8 weeks]

   Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined

8. Seated DBP Control Rate at Trough [8 weeks]

   DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing

9. Seated SBP Control Rate at Trough [8 weeks]

   SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing

10. Seated DBP Response Rate at Trough [8 weeks]

    DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing

11. Seated SBP Response Rate at Trough [8 weeks]

    SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing

12. Seated Blood Pressure (BP) Normalisation at Trough [8 weeks]

    Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All

Inclusion criteria:

1. Essential hypertensive patients

• If already taking antihypertensive drugs, mean seated diastolic blood pressure (DBP) must be >=90 and >=114 mmHg

• If not taking any antihypertensive drugs, mean seated DBP must be >=95 and >=114 mmHg

1. Able to stop all current antihypertensive drugs without risk to the patient based on the investigators opinion.

Exclusion criteria:

1. Patients taking 3 or more antihypertensive drugs at signing the informed consent form

2. Patients with known or suspected secondary hypertension

3. Patients with clinically relevant cardiac arrhythmia

4. Congestive heart failure with New York Heart Association (NYHA) functional class III-IV

5. Patients with recent cardiovascular events

6. Patients with a history of stroke or transient ischaemic attack within last 6 months before signing the informed consent form

7. Patients with a history of sudden deterioration of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors; or patients with post-renal transplant or post-nephrectomy

8. Patients who have previously experienced characteristic symptoms of angioedema (such as facial, tongue, pharyngeal, or laryngeal swelling with dyspnea) during treatment with ARBs or ACE inhibitors

9. Patients with known hypersensitivity to any component of the investigational product, or a known hypersensitivity to dihydropyridine-derived drugs

10. Patients with hepatic and/or renal dysfunction

11. Pre-menopausal women who are nursing or pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1235.37.01 Boehringer Ingelheim Investigational Site	Chuo-ku,Tokyo		Japan
2	1235.37.07 Boehringer Ingelheim Investigational Site	Hiroshima, Hiroshima		Japan
3	1235.37.08 Boehringer Ingelheim Investigational Site	Itoshima, Fukuoka		Japan
4	1235.37.02 Boehringer Ingelheim Investigational Site	Katsushika-ku, Tokyo		Japan
5	1235.37.05 Boehringer Ingelheim Investigational Site	Osaka, Osaka		Japan
6	1235.37.03 Boehringer Ingelheim Investigational Site	Ota-ku, Tokyo		Japan
7	1235.37.06 Boehringer Ingelheim Investigational Site	Suita, Osaka		Japan
8	1235.37.04 Boehringer Ingelheim Investigational Site	Yokohama, Kanagawa		Japan

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01286558
• Other Study ID Numbers: 1235.37
• First Posted: Jan 31, 2011
• Last Update Posted: Jun 27, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Hypertension; Amlodipine; Telmisartan

Study Results

Participant Flow

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Period Title: Overall Study
STARTED	112	113
COMPLETED	111	111
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	112	113	225
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	54.6 (8.4)	52.8 (9.4)	53.7 (8.9)
Sex: Female, Male (Count of Participants)
Female	23 20.5%	24 21.2%	47 20.9%
Male	89 79.5%	89 78.8%	178 79.1%

Outcome Measures

1. Primary Outcome

Title	Reduction From the Reference Baseline in Mean Seated Diastolic Blood Pressure (DBP) at Trough
Description	Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
Time Frame	Reference baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS)

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	112	112
Least Squares Mean (Standard Error) [mm Hg]	4.93 (0.61)	3.47 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	80 mg Telmisartan and 5 mg Amlodipine FDC, 40 mg Telmisartan and 5 mg Amlodipine FDC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.46
	Confidence Interval	() 95%; -0.22 to 3.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Reduction From the Reference Baseline in Mean Seated Systolic Blood Pressure (SBP) at Trough
Description	Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined At trough: 24-hour post-dosing
Time Frame	Reference baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	112	112
Least Squares Mean (Standard Error) [mm Hg]	5.55 (0.90)	3.41 (0.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	80 mg Telmisartan and 5 mg Amlodipine FDC, 40 mg Telmisartan and 5 mg Amlodipine FDC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.14
	Confidence Interval	() 95%; -0.36 to 4.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Changes From the Reference Baseline in the 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean (Relative to Dose Time) for DBP
Description	Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Time Frame	Reference baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	105	107
Least Squares Mean (Standard Error) [mm Hg]	-1.54 (0.49)	-0.33 (0.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	80 mg Telmisartan and 5 mg Amlodipine FDC, 40 mg Telmisartan and 5 mg Amlodipine FDC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.21
	Confidence Interval	() 95%; -2.58 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Changes From the Reference Baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
Description	Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Time Frame	Reference baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	105	107
Least Squares Mean (Standard Error) [mm Hg]	-2.81 (0.81)	-0.91 (0.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	80 mg Telmisartan and 5 mg Amlodipine FDC, 40 mg Telmisartan and 5 mg Amlodipine FDC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.90
	Confidence Interval	() 95%; -4.16 to 0.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for DBP
Description	Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined
Time Frame	Pseudo-baseline, 14 weeks

Outcome Measure Data

Analysis Population Description

ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	105	107
Least Squares Mean (Standard Error) [mm Hg]	-12.16 (0.61)	-11.28 (0.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	80 mg Telmisartan and 5 mg Amlodipine FDC, 40 mg Telmisartan and 5 mg Amlodipine FDC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.89
	Confidence Interval	() 95%; -2.57 to 0.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Changes From the Pseudo-baseline in the 24-hour ABPM Mean (Relative to Dose Time) for SBP
Description	Pseudo-baseline: Status of patients after the 6-week open-label run-in period with telmisartan monotherapy, where patients' eligibility to enter the double-blind treatment period was examined
Time Frame	Pseudo-baseline, 14 weeks

Outcome Measure Data

Analysis Population Description

ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	105	107
Least Squares Mean (Standard Error) [mm Hg]	-20.96 (0.96)	-19.32 (0.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	80 mg Telmisartan and 5 mg Amlodipine FDC, 40 mg Telmisartan and 5 mg Amlodipine FDC
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.64
	Confidence Interval	() 95%; -4.27 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Changes From the Reference Baseline in DBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
Description	Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Time Frame	Reference baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	105	107
Hour 1	-1.04 (10.27)	-0.22 (12.38)
Hour 2	-1.95 (11.44)	0.32 (10.93)
Hour 3	-2.25 (11.86)	2.87 (11.61)
Hour 4	-3.69 (12.43)	-0.02 (10.63)
Hour 5	-1.39 (13.22)	-0.75 (14.06)
Hour 6	-1.58 (11.08)	-0.86 (13.32)
Hour 7	-0.40 (12.24)	-1.25 (13.22)
Hour 8	-1.58 (13.23)	0.55 (13.83)
Hour 9	-2.77 (12.83)	-0.73 (12.44)
Hour 10	-2.80 (13.75)	-0.14 (11.58)
Hour 11	-1.47 (11.58)	-1.16 (12.05)
Hour 12	-0.74 (11.86)	-1.43 (13.65)
Hour 13	-2.33 (12.96)	-1.05 (12.03)
Hour 14	-0.53 (15.49)	-0.08 (11.36)
Hour 15	-0.36 (13.65)	1.86 (10.88)
Hour 16	-0.01 (10.73)	0.85 (10.97)
Hour 17	0.70 (12.16)	-0.80 (11.07)
Hour 18	-1.89 (11.81)	1.02 (10.33)
Hour 19	-3.12 (12.96)	0.10 (10.38)
Hour 20	0.23 (11.03)	-1.27 (11.93)
Hour 21	-3.25 (12.85)	-0.90 (10.81)
Hour 22	-2.00 (11.83)	-1.67 (13.14)
Hour 23	-2.07 (12.05)	-0.53 (11.95)
Hour 24	-0.82 (9.37)	0.42 (11.23)

8. Secondary Outcome

Title	Changes From the Reference Baseline in SBP Hourly Mean Over the 24-hour Dosing Interval as Measured by ABPM
Description	Reference baseline: Status of patients after the 12-week open-label run-in period with telmisartan monotherapy followed by 40 mg telmisartan and 5 mg amlodipine combination therapy, where patients' eligibility to enter the double-blind treatment period was examined
Time Frame	Reference baseline, 8 weeks

Outcome Measure Data

Analysis Population Description

ABPM set, i.e., a subset of FAS and with patients who had available ABPM measurements

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	105	107
Hour 1	-6.54 (16.03)	-1.78 (16.37)
Hour 2	-2.78 (14.98)	-0.28 (15.82)
Hour 3	-3.41 (16.83)	2.72 (17.74)
Hour 4	-4.72 (18.42)	-1.88 (17.03)
Hour 5	-1.14 (18.23)	-2.54 (20.71)
Hour 6	-1.68 (18.39)	-2.48 (20.01)
Hour 7	-0.60 (19.12)	-2.45 (18.69)
Hour 8	-2.05 (20.40)	-0.27 (22.07)
Hour 9	-3.09 (17.35)	-1.17 (18.33)
Hour 10	-5.78 (19.61)	-0.70 (18.91)
Hour 11	-2.04 (19.59)	0.69 (15.16)
Hour 12	-4.57 (17.54)	0.61 (16.89)
Hour 13	-2.27 (19.90)	0.26 (17.53)
Hour 14	-1.46 (21.12)	-1.09 (17.49)
Hour 15	-1.21 (17.86)	1.41 (17.70)
Hour 16	-0.78 (17.18)	0.68 (15.42)
Hour 17	-0.71 (17.58)	-1.16 (15.67)
Hour 18	-2.66 (18.90)	1.01 (15.84)
Hour 19	-4.58 (18.92)	-1.24 (15.30)
Hour 20	0.57 (19.07)	-3.56 (17.02)
Hour 21	-4.02 (17.27)	-1.20 (16.47)
Hour 22	-3.88 (16.81)	-4.12 (17.40)
Hour 23	-4.65 (21.01)	-2.71 (16.15)
Hour 24	-2.24 (16.51)	0.29 (16.09)

9. Secondary Outcome

Title	Seated DBP Control Rate at Trough
Description	DBP control rate: The rate of patients with controlled seated DBP at trough of less than 90 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Patients included in FAS and with seated DBP >=90 mmHg at reference baseline

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	49	50
No	53.1 47.4%	60.0 53.1%
Yes	46.9 41.9%	40.0 35.4%

10. Secondary Outcome

Title	Seated SBP Control Rate at Trough
Description	SBP control rate: The rate of patients with controlled seated DBP at trough of less than 140 mmHg after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

Patients included in FAS and with seated SBP >=140 mmHg at reference baseline

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	29	38
No	55.2 49.3%	55.3 48.9%
Yes	44.8 40%	44.7 39.6%

11. Secondary Outcome

Title	Seated DBP Response Rate at Trough
Description	DBP response rate: The rate of patients who achieved an adequate response in seated DBP at trough (<90 mmHg and/or reduction from reference baseline >=10 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	112	112
No	29.5 26.3%	32.1 28.4%
Yes	70.5 62.9%	67.9 60.1%

12. Secondary Outcome

Title	Seated SBP Response Rate at Trough
Description	SBP response rate: The rate of patients who achieved an adequate response in seated SBP at trough (<140 mmHg and/or reduction from reference baseline >=20 mmHg) after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	112	112
No	19.6 17.5%	17.9 15.8%
Yes	80.4 71.8%	82.1 72.7%

13. Secondary Outcome

Title	Seated Blood Pressure (BP) Normalisation at Trough
Description	Seated blood pressure (BP) normalisation: The numbers of patients whose blood pressure was within normalisation criterion in terms of seated blood pressure after the 8-week double-blind period At trough: 24-hour post-dosing
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC	40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
Measure Participants	112	112
No	41 36.6%	44 38.9%
Optimal	21 18.8%	13 11.5%
Normal	23 20.5%	26 23%
High-normal	27 24.1%	29 25.7%

Adverse Events

Time Frame	From first drug administration in the double-blind treatment period until 24 hours after the last dose, up to 69 days
Arm/Group Title	80 mg Telmisartan and 5 mg Amlodipine FDC		40 mg Telmisartan and 5 mg Amlodipine FDC
Arm/Group Description
All Cause Mortality
	80 mg Telmisartan and 5 mg Amlodipine FDC		40 mg Telmisartan and 5 mg Amlodipine FDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	80 mg Telmisartan and 5 mg Amlodipine FDC		40 mg Telmisartan and 5 mg Amlodipine FDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/112 (0.9%)		1/113 (0.9%)
Injury, poisoning and procedural complications
Clavicle fracture	0/112 (0%)		1/113 (0.9%)
Nervous system disorders
Cerebral artery occlusion	1/112 (0.9%)		0/113 (0%)
Other (Not Including Serious) Adverse Events
	80 mg Telmisartan and 5 mg Amlodipine FDC		40 mg Telmisartan and 5 mg Amlodipine FDC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/112 (5.4%)		6/113 (5.3%)
Infections and infestations
Nasopharyngitis	6/112 (5.4%)		6/113 (5.3%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.