Trial Outcomes & Findings for Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients (NCT NCT00879411)

Results Overview

Change from baseline in 24h systolic blood pressure (BP) at week 8

Recruitment status

COMPLETED

Target enrollment

670 participants

Primary outcome timeframe

baseline to 8 weeks

Results posted on

2014-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Telmisartan, Hydrochlorothiazide
Overall Study STARTED	701
Overall Study COMPLETED	539
Overall Study NOT COMPLETED	162

Reasons for withdrawal

Reasons for withdrawal
Measure	Telmisartan, Hydrochlorothiazide
Overall Study lost to follow-up (non-AE)	162

Baseline Characteristics

Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telmisartan, Hydrochlorothiazide n=701 Participants
Age, Continuous	60.5 Year STANDARD_DEVIATION 12.8 • n=99 Participants
Gender Female	324 participants n=99 Participants
Gender Male	357 participants n=99 Participants
Baseline Diastolic Blood Pressure (DBP) values (ABPM)	82 mm Hg STANDARD_DEVIATION 9.6 • n=99 Participants
Baseline Systolic Blood Pressure (SBP) values (ABPM)	136 mm Hg STANDARD_DEVIATION 13.2 • n=99 Participants

PRIMARY outcome

Timeframe: baseline to 8 weeks

Population: Intention to Treat (ITT)

Change from baseline in 24h systolic blood pressure (BP) at week 8

Outcome measures

Outcome measures
Measure	Telmisartan, Hydrochlorothiazide n=537 Participants
Efficacy (Change of Systolic Blood Pressure)	8.6 mm Hg Standard Deviation 17.8

PRIMARY outcome

Timeframe: baseline to 8 weeks

Change from baseline in 24h diastolic blood pressure (BP) at week 8

Outcome measures

Outcome measures
Measure	Telmisartan, Hydrochlorothiazide n=537 Participants
Efficacy (Change of Diastolic Blood Pressure)	4.7 mm Hg Standard Deviation 12.7

SECONDARY outcome

Timeframe: 8 weeks

Safety and tolerability of Micardis® in the treatment of patients with hypertension over 8 weeks, using 10 point Likert scale with worst score=1, best score=10

Outcome measures

Outcome measures
Measure	Telmisartan, Hydrochlorothiazide n=537 Participants
Overall Tolerability Scale	9.2 units on a scale Standard Deviation 1.5

Adverse Events

Telmisartan, Hydrochlorothiazide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

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