Trial Outcomes & Findings for Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension (NCT NCT00926289)

NCT ID: NCT00926289

Last Updated: 2014-06-27

Results Overview

The SBP value at baseline was subtracted from the SBP value at Week 7.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 894 participants
• Primary outcome timeframe: Baseline and Week 7
• Results posted on: 2014-06-27

Participant Flow

894 patients were entered (randomised) into the study; however, of these, 6 were not treated. Therefore 888 patients actually entered into treatment.

Participant milestones

Measure	Telmisartan 40/80 mg Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Study STARTED	294	594
Overall Study COMPLETED	269	558
Overall Study NOT COMPLETED	25	36

Reasons for withdrawal

Measure	Telmisartan 40/80 mg Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Study Adverse Event	9	11
Overall Study Protocol Violation	8	12
Overall Study Lost to Follow-up	3	6
Overall Study Withdrawal by Subject	4	4
Overall Study Other	1	3

Baseline Characteristics

Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

Baseline characteristics by cohort

Measure	Telmisartan 40/80 mg n=294 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=594 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks	Total n=888 Participants Total of all reporting groups
Age, Continuous	57.6 Years STANDARD_DEVIATION 11.9 • n=5 Participants	56.8 Years STANDARD_DEVIATION 11.3 • n=7 Participants	57.0 Years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	285 Participants n=7 Participants	410 Participants n=5 Participants
Sex: Female, Male Male	169 Participants n=5 Participants	309 Participants n=7 Participants	478 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 7

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

The SBP value at baseline was subtracted from the SBP value at Week 7.

Outcome measures

Measure	Telmisartan 40/80 mg n=263 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=541 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7	-28.5 mmHg Standard Error 0.88	-37.0 mmHg Standard Error 0.62

SECONDARY outcome

Timeframe: Baseline and Week 5

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

The SBP value at baseline was subtracted from the SBP value at Week 5.

Outcome measures

Measure	Telmisartan 40/80 mg n=270 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=550 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Change From Baseline in Mean Seated Trough Cuff SBP to Week 5	-28.6 mmHg Standard Error 0.86	-35.8 mmHg Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline and Week 3

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

The SBP value at baseline was subtracted from the SBP value at Week 3.

Outcome measures

Measure	Telmisartan 40/80 mg n=276 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=567 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Change From Baseline in Mean Seated Trough Cuff SBP to Week 3	-26.5 mmHg Standard Error 0.87	-33.3 mmHg Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline and Week 7

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

The DBP value at baseline was subtracted from the DBP value at Week 7.

Outcome measures

Measure	Telmisartan 40/80 mg n=263 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=541 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7	-15.4 mmHg Standard Error 0.55	-18.6 mmHg Standard Error 0.38

SECONDARY outcome

Timeframe: Week 7 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

SBP control is defined as SBP < 140 mmHg.

Outcome measures

Measure	Telmisartan 40/80 mg n=285 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=573 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7	122 Participants	363 Participants

SECONDARY outcome

Timeframe: Week 5 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

SBP control is defined as SBP < 140 mmHg

Outcome measures

Measure	Telmisartan 40/80 mg n=284 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=572 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5	119 Participants	355 Participants

SECONDARY outcome

Timeframe: Week 3 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

SBP control is defined as SBP < 140 mmHg

Outcome measures

Measure	Telmisartan 40/80 mg n=276 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=567 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3	97 Participants	306 Participants

SECONDARY outcome

Timeframe: Week 7 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

DBP control is defined as DBP<90 mmHg

Outcome measures

Measure	Telmisartan 40/80 mg n=285 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=573 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7	150 Participants	389 Participants

SECONDARY outcome

Timeframe: Week 5 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

DBP control is defined as DBP<90 mmHg

Outcome measures

Measure	Telmisartan 40/80 mg n=284 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=572 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5	150 participants	391 participants

SECONDARY outcome

Timeframe: Week 3 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

DBP control is defined as DBP<90 mmHg

Outcome measures

Measure	Telmisartan 40/80 mg n=276 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=567 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3	131 Participants	343 Participants

SECONDARY outcome

Timeframe: Week 7 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP

Outcome measures

Measure	Telmisartan 40/80 mg n=285 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=573 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With Blood Pressure (BP) Control at Week 7	99 Participants	318 Participants

SECONDARY outcome

Timeframe: Week 7 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP

Outcome measures

Measure	Telmisartan 40/80 mg n=285 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=573 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With BP Control at Week 7	99 Participants	318 Participants

SECONDARY outcome

Timeframe: Week 7 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg

Outcome measures

Measure	Telmisartan 40/80 mg n=285 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=573 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7	233 Participants	527 Participants

SECONDARY outcome

Timeframe: Week 7 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg

Outcome measures

Measure	Telmisartan 40/80 mg n=285 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=573 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Number of Participants With DBP Response at Week 7	202 Participants	483 Participants

SECONDARY outcome

Timeframe: Week 7 timepoint

Population: The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm

BP categories comprise:

• BP optimal (SBP <120 mmHg and DBP <80 mmHg)
• BP normal (SBP <130 mmHg and DBP <85 mmHg but not 'optimal')
• BP high normal (SBP <140 mmHg and DBP <90 mmHg but not 'normal')
• Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not 'high normal')
• Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not 'Grade 1 hypertension')
• Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)

Outcome measures

Measure	Telmisartan 40/80 mg n=285 Participants Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=573 Participants fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
BP Categories at Week 7 BP high normal	57 Participants	138 Participants
BP Categories at Week 7 BP optimal	6 Participants	44 Participants
BP Categories at Week 7 BP normal	36 Participants	136 Participants
BP Categories at Week 7 Grade 1 hypertension	120 Participants	186 Participants
BP Categories at Week 7 Grade 2 hypertension	44 Participants	58 Participants
BP Categories at Week 7 Grade 3 hypertension	22 Participants	11 Participants

Adverse Events

Telmisartan 40/80 mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Telmisartan 40/80 mg + HCTZ 12.5/25 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telmisartan 40/80 mg n=294 participants at risk Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks	Telmisartan 40/80 mg + HCTZ 12.5/25 mg n=594 participants at risk fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Nervous system disorders Epilepsy	0.34% 1/294 • 7 weeks	0.00% 0/594 • 7 weeks

Other adverse events

Adverse event data not reported

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