Trial Outcomes & Findings for Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension (NCT NCT00553267)

NCT ID: NCT00553267

Last Updated: 2014-02-13

Results Overview

Change from baseline to the end of study in trough DBP

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 947 participants
• Primary outcome timeframe: Baseline and end of study (8 weeks or last value on treatment)
• Results posted on: 2014-02-13

Participant Flow

Participant milestones

Measure	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 10mg	Telmisartan 80mg and Amlodipine 10mg
Overall Study STARTED	315	315	317
Overall Study COMPLETED	301	297	307
Overall Study NOT COMPLETED	14	18	10

Reasons for withdrawal

Measure	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 10mg	Telmisartan 80mg and Amlodipine 10mg
Overall Study Adverse Event	8	10	5
Overall Study Non compliant with protocol	3	3	2
Overall Study Lost to Follow-up	0	0	1
Overall Study Consent withdrawn	2	3	1
Overall Study Specified category	1	2	1

Baseline Characteristics

Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

Baseline characteristics by cohort

Measure	Amlodipine 10mg n=315 Participants	Telmisartan 40mg and Amlodipine 10mg n=315 Participants	Telmisartan 80mg and Amlodipine 10mg n=317 Participants	Total n=947 Participants Total of all reporting groups
Age, Continuous	56.4 Years STANDARD_DEVIATION 10.4 • n=5 Participants	57.6 Years STANDARD_DEVIATION 9.4 • n=7 Participants	55.5 Years STANDARD_DEVIATION 9.8 • n=5 Participants	56.5 Years STANDARD_DEVIATION 9.9 • n=4 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	145 Participants n=7 Participants	146 Participants n=5 Participants	419 Participants n=4 Participants
Sex: Female, Male Male	187 Participants n=5 Participants	170 Participants n=7 Participants	171 Participants n=5 Participants	528 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and end of study (8 weeks or last value on treatment)

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

Change from baseline to the end of study in trough DBP

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Change From Baseline in Trough Seated Diastolic Blood Pressure	-6.48 mmHg Standard Error 0.45	-9.24 mmHg Standard Error 0.45	-9.33 mmHg Standard Error 0.45

SECONDARY outcome

Timeframe: Baseline and end of study (8 weeks or last value on treatment)

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

Change from baseline to the end of study in trough SBP

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Change From Baseline in Trough Seated Systolic Blood Pressure	-7.44 mmHg Standard Error 0.66	-11.09 mmHg Standard Error 0.66	-11.29 mmHg Standard Error 0.66

SECONDARY outcome

Timeframe: End of study (8 weeks or last value on treatment)

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

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

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) Yes (DBP<90 mmHg)	156 Participants	195 Participants	206 Participants
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) No (DBP>=90 mmHg)	149 Participants	111 Participants	104 Participants

SECONDARY outcome

Timeframe: End of study (8 weeks or last value on treatment)

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

The number of patients who reach the target DBP of <80mmHg

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Trough Seated Diastolic Blood Pressure <80 mmHg Yes (DBP<80 mmHg)	18 Participants	39 Participants	39 Participants
Trough Seated Diastolic Blood Pressure <80 mmHg No (DBP>=80 mmHg)	287 Participants	267 Participants	271 Participants

SECONDARY outcome

Timeframe: End of study (8 weeks or last value on treatment)

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

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

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Trough Seated DBP Response Yes (Responder)	163 Participants	202 Participants	213 Participants
Trough Seated DBP Response No (Non-responder)	142 Participants	104 Participants	97 Participants

SECONDARY outcome

Timeframe: End of study (8 weeks or last value on treatment)

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

The number of patients who reach the target SBP of <140mmHg

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Trough Seated SBP Control Yes (SBP<140 mmHg)	153 Participants	180 Participants	187 Participants
Trough Seated SBP Control No (SBP>=140 mmHg)	152 Participants	126 Participants	123 Participants

SECONDARY outcome

Timeframe: End of study (8 weeks or last value on treatment)

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

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

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Trough Seated SBP Response Yes (Responder)	165 Participants	198 Participants	204 Participants
Trough Seated SBP Response No (Non-responder)	140 Participants	108 Participants	106 Participants

SECONDARY outcome

Timeframe: End of study (8 weeks or last value on treatment)

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

The number of patients who reach predefined BP categories

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Trough Seated BP Normality Classes Optimal (SBP<120 and DBP<80 mmHg)	0 Participants	12 Participants	6 Participants
Trough Seated BP Normality Classes Normal (SBP<130 and DBP<85 mmHg and not optimal)	36 Participants	43 Participants	50 Participants
Trough Seated BP Normality Classes High-normal (SBP<140 DBP<90 mmHg and not normal)	77 Participants	91 Participants	106 Participants
Trough Seated BP Normality Classes Stage 1 hypertension (SBP<160 and DBP<100 mmHg)	157 Participants	139 Participants	133 Participants
Trough Seated BP Normality Classes Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg)	35 Participants	21 Participants	15 Participants

SECONDARY outcome

Timeframe: During randomised treatment period

Population: Full analysis set of patients who had a baseline trough blood pressure measurement and at least one post baseline trough blood pressure measurement using last observation carried forward

The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Oedema Incidence Rate	44.7 Number of patients/100 patient-years	42.8 Number of patients/100 patient-years	54.0 Number of patients/100 patient-years

SECONDARY outcome

Timeframe: During randomised treatment period

The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)

Outcome measures

Measure	Amlodipine 10mg n=305 Participants	Telmisartan 40mg and Amlodipine 10mg n=306 Participants	Telmisartan 80mg and Amlodipine 10mg n=310 Participants
Peripheral Oedema Incidence Rate	48.8 Number of cases/100 patient-years	44.8 Number of cases/100 patient-years	54.0 Number of cases/100 patient-years

Adverse Events

Amlodipine 10mg

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Telmisartan 40mg and Amlodipine 10mg

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Telmisartan 80mg and Amlodipine 10mg

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 10mg	Telmisartan 80mg and Amlodipine 10mg
Cardiac disorders Cardiac failure	0.00% 0/315	0.32% 1/315	0.00% 0/317
General disorders Local swelling	0.00% 0/315	0.32% 1/315	0.00% 0/317
Infections and infestations Bronchitis	0.32% 1/315	0.00% 0/315	0.00% 0/317
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/315	0.32% 1/315	0.00% 0/317

Other adverse events

Measure	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 10mg	Telmisartan 80mg and Amlodipine 10mg
General disorders Peripheral oedema	7.0% 22/315	6.7% 21/315	8.5% 27/317

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER