Trial Outcomes & Findings for Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension (NCT NCT00558428)

NCT ID: NCT00558428

Last Updated: 2014-06-27

Results Overview

Change from baseline to the end of study in trough DBP

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1098 participants
• Primary outcome timeframe: End of study (8 weeks or last value on treatment)
• Results posted on: 2014-06-27

Participant Flow

1487 were enrolled, 1098 entered but 1 patient not treated.

Participant milestones

Measure	Amlodipine 5mg	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg
Overall Study STARTED	267	276	277	277
Overall Study COMPLETED	255	252	273	266
Overall Study NOT COMPLETED	12	24	4	11

Reasons for withdrawal

Measure	Amlodipine 5mg	Amlodipine 10mg	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg
Overall Study Adverse Event	6	22	3	4
Overall Study Lost to Follow-up	0	1	0	0
Overall Study Lack of Efficacy	0	0	1	2
Overall Study Non compliant with protocol	1	0	0	3
Overall Study Consent withdrawn	2	1	0	1
Overall Study Other	3	0	0	1

Baseline Characteristics

Telmisartan/Amlodipine (80/5) vs. Telmisartan/Amlodipine (40/5) vs. Amlodipine 10 or 5 in Resistant Hypertension

Baseline characteristics by cohort

Measure	Amlodipine 5mg n=267 Participants	Amlodipine 10mg n=276 Participants	Telmisartan 40mg and Amlodipine 5mg n=277 Participants	Telmisartan 80mg and Amlodipine 5mg n=277 Participants	Total n=1097 Participants Total of all reporting groups
Age, Continuous	54 Years STANDARD_DEVIATION 10.6 • n=5 Participants	54.3 Years STANDARD_DEVIATION 10.6 • n=7 Participants	53.9 Years STANDARD_DEVIATION 11 • n=5 Participants	54.5 Years STANDARD_DEVIATION 10.2 • n=4 Participants	54.2 Years STANDARD_DEVIATION 10.6 • n=21 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	100 Participants n=7 Participants	117 Participants n=5 Participants	94 Participants n=4 Participants	415 Participants n=21 Participants
Sex: Female, Male Male	163 Participants n=5 Participants	176 Participants n=7 Participants	160 Participants n=5 Participants	183 Participants n=4 Participants	682 Participants n=21 Participants

PRIMARY 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 full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure

Change from baseline to the end of study in trough DBP

Outcome measures

Measure	Amlodipine 5mg n=255 Participants	Amlodipine 10mg n=261 Participants	Telmisartan 40mg and Amlodipine 5mg n=270 Participants	Telmisartan 80mg and Amlodipine 5mg n=271 Participants
Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP)	-5.71 mmHg Standard Error 0.49	-7.95 mmHg Standard Error 0.49	-9.35 mmHg Standard Error 0.48	-10.63 mmHg Standard Error 0.48

PRIMARY outcome

Timeframe: During randomised treatment period (8 weeks was the planned end of treatment, some of the measurements analysed as end of study can be at 4 weeks or at any point on randomised treatment)

Population: The treated set (TS) consisted of all patients that took at least one dose of the double-blind treatment (n=1097)

Patients from the treated set who experienced at least one case of general oedema.

Outcome measures

Measure	Amlodipine 5mg n=255 Participants	Amlodipine 10mg n=261 Participants	Telmisartan 40mg and Amlodipine 5mg n=270 Participants	Telmisartan 80mg and Amlodipine 5mg n=271 Participants
Number of Patients With Oedema Number of patients with any oedema	23 patients	76 patients	14 patients	10 patients
Number of Patients With Oedema Number of patients with general oedema	23 patients	75 patients	14 patients	10 patients

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 full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure

Change from baseline to the end of study in trough SBP

Outcome measures

Measure	Amlodipine 5mg n=255 Participants	Amlodipine 10mg n=261 Participants	Telmisartan 40mg and Amlodipine 5mg n=270 Participants	Telmisartan 80mg and Amlodipine 5mg n=271 Participants
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP)	-6.18 mmHg Standard Error 0.73	-11.11 mmHg Standard Error 0.72	-13.56 mmHg Standard Error 0.71	-14.99 mmHg Standard Error 0.71

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 full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure

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

Outcome measures

Measure	Amlodipine 5mg n=255 Participants	Amlodipine 10mg n=261 Participants	Telmisartan 40mg and Amlodipine 5mg n=270 Participants	Telmisartan 80mg and Amlodipine 5mg n=271 Participants
Trough Seated Diastolic Blood Pressure Control No (DBP>=90 mmHg)	148 patients	113 patients	117 patients	98 patients
Trough Seated Diastolic Blood Pressure Control Yes (DBP<90 mmHg)	107 patients	148 patients	153 patients	173 patients

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 full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure

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

Outcome measures

Measure	Amlodipine 5mg n=255 Participants	Amlodipine 10mg n=261 Participants	Telmisartan 40mg and Amlodipine 5mg n=270 Participants	Telmisartan 80mg and Amlodipine 5mg n=271 Participants
Trough Seated DBP Response Yes (Responder)	116 patients	163 patients	177 patients	187 patients
Trough Seated DBP Response No (Non-responder)	139 patients	98 patients	93 patients	84 patients

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 full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure

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

Outcome measures

Measure	Amlodipine 5mg n=255 Participants	Amlodipine 10mg n=261 Participants	Telmisartan 40mg and Amlodipine 5mg n=270 Participants	Telmisartan 80mg and Amlodipine 5mg n=271 Participants
Trough Seated SBP Control No (SBP>=140 mmHg)	155 patients	119 patients	108 patients	93 patients
Trough Seated SBP Control Yes (SBP<140 mmHg)	100 patients	142 patients	162 patients	178 patients

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 full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure

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

Outcome measures

Measure	Amlodipine 5mg n=255 Participants	Amlodipine 10mg n=261 Participants	Telmisartan 40mg and Amlodipine 5mg n=270 Participants	Telmisartan 80mg and Amlodipine 5mg n=271 Participants
Trough Seated SBP Response Yes (Responder)	118 patients	166 patients	187 patients	200 patients
Trough Seated SBP Response No (Non-responder)	137 patients	95 patients	83 patients	71 patients

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 full analysis set included patients who had baseline and at least one post baseline trough measure of blood pressure

The number of patients who reach predefined BP categories:

• Optimal - SBP<120 and DBP<80 mmHg
• Normal - SBP<130 and DBP<85 mmHg
• High-normal - SBP<140 DBP<90 mmHg
• Stage 1 hypertension - SBP<160 and DBP<100
• Stage 2 hypertension SBP>=160 and DBP>=100 mmHg

Outcome measures

Measure	Amlodipine 5mg n=255 Participants	Amlodipine 10mg n=261 Participants	Telmisartan 40mg and Amlodipine 5mg n=270 Participants	Telmisartan 80mg and Amlodipine 5mg n=271 Participants
Trough Seated Blood Pressure (BP) Normality Classes Optimal	2 patients	5 patients	19 patients	21 patients
Trough Seated Blood Pressure (BP) Normality Classes Normal	23 patients	30 patients	35 patients	51 patients
Trough Seated Blood Pressure (BP) Normality Classes High-normal	42 patients	68 patients	63 patients	67 patients
Trough Seated Blood Pressure (BP) Normality Classes Stage 1 hypertension	118 patients	126 patients	127 patients	110 patients
Trough Seated Blood Pressure (BP) Normality Classes Stage 2 hypertension	70 patients	32 patients	26 patients	22 patients

Adverse Events

Amlodipine 5mg

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Amlodipine 10mg

Serious events: 1 serious events

Other events: 74 other events

Deaths: 0 deaths

Telmisartan 40mg and Amlodipine 5mg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Telmisartan 80mg and Amlodipine 5mg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Amlodipine 5mg n=267 participants at risk	Amlodipine 10mg n=276 participants at risk	Telmisartan 40mg and Amlodipine 5mg n=277 participants at risk	Telmisartan 80mg and Amlodipine 5mg n=277 participants at risk
Cardiac disorders Atrial fibrilation	0.37% 1/267 • From day of first dose until one day after last dose	0.00% 0/276 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose
General disorders Chest discomfort	0.00% 0/267 • From day of first dose until one day after last dose	0.00% 0/276 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose	0.36% 1/277 • From day of first dose until one day after last dose
General disorders Chest pain	0.37% 1/267 • From day of first dose until one day after last dose	0.00% 0/276 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose
Infections and infestations Pneumonia	0.00% 0/267 • From day of first dose until one day after last dose	0.00% 0/276 • From day of first dose until one day after last dose	0.36% 1/277 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/267 • From day of first dose until one day after last dose	0.00% 0/276 • From day of first dose until one day after last dose	0.36% 1/277 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose
Reproductive system and breast disorders Breast mass	0.00% 0/267 • From day of first dose until one day after last dose	0.36% 1/276 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose	0.00% 0/277 • From day of first dose until one day after last dose

Other adverse events

Measure	Amlodipine 5mg n=267 participants at risk	Amlodipine 10mg n=276 participants at risk	Telmisartan 40mg and Amlodipine 5mg n=277 participants at risk	Telmisartan 80mg and Amlodipine 5mg n=277 participants at risk
General disorders Oedema peripheral	8.2% 22/267 • From day of first dose until one day after last dose	26.8% 74/276 • From day of first dose until one day after last dose	5.1% 14/277 • From day of first dose until one day after last dose	3.6% 10/277 • From day of first dose until one day after last dose

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