Trial Outcomes & Findings for An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice (NCT NCT00982735)

NCT ID: NCT00982735

Last Updated: 2014-04-16

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 987 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2014-04-16

Participant Flow

Participant milestones

Measure	Telmisartan 40mg or Telmisartan 80 mg Once a Day Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
Overall Study STARTED	987
Overall Study COMPLETED	757
Overall Study NOT COMPLETED	230

Reasons for withdrawal

Measure	Telmisartan 40mg or Telmisartan 80 mg Once a Day Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
Overall Study Lost to Follow-up	6
Overall Study Patient ineligible for trial	224

Baseline Characteristics

An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice

Baseline characteristics by cohort

Measure	Telmisartan 40mg or Telmisartan 80 mg Once a Day n=987 Participants Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
Age, Continuous	50.12 years STANDARD_DEVIATION 8.54 • n=5 Participants
Gender Female	313 participants n=5 Participants
Gender Male	647 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Telmisartan 40mg or Telmisartan 80 mg Once a Day n=757 Participants Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.	711 Participants

SECONDARY outcome

Timeframe: 24 weeks

A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding).

Outcome measures

Measure	Telmisartan 40mg or Telmisartan 80 mg Once a Day n=757 Participants Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion Marginal	21 Participants
Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion Not satisfactory	3 Participants
Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion Outstanding	221 Participants
Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion Satisfactory	159 Participants
Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion Very satisfactory	363 Participants

SECONDARY outcome

Timeframe: Baseline and 24 weeks

Outcome measures

Measure	Telmisartan 40mg or Telmisartan 80 mg Once a Day n=757 Participants Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
Change From Baseline in Microalbuminuria at 24 Weeks No microalbuminuria at baseline (BL) and at week24	433 Participants
Change From Baseline in Microalbuminuria at 24 Weeks No microalbuminuria BL and 30 mg/g Crea at week24	5 Participants
Change From Baseline in Microalbuminuria at 24 Weeks No microalbuminuria BL and 100 mg/g Crea at week24	1 Participants
Change From Baseline in Microalbuminuria at 24 Weeks No microalbuminuria BL and 500 mg/g Crea at week24	0 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 30 mg/g Crea BL and no microalbuminuria at week24	111 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 30mg/g Crea at BL and at week24	25 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 30mg/g Crea at BL and 100mg/g Crea at week24	1 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 30mg/g Crea at BL and 500mg/g Crea at week24	0 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 100 mg/g Crea BL and no microalbum.uria at week24	58 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 100mg/g Crea at BL and 30mg/g Crea at week24	84 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 100mg/g Crea at BL and at week24	11 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 100mg/g Crea at BL and 500mg/g Crea at week24	0 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 500mg/g Crea at BL + no microalbuminuria at week24	8 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 500mg/g Crea at BL + 30mg/g Crea at week24	7 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 500mg/g Crea at BL and 100mg/g Crea at week24	12 Participants
Change From Baseline in Microalbuminuria at 24 Weeks 500mg/g Crea at BL and at week24	1 Participants

Adverse Events

Telmisartan 40mg or Telmisartan 80 mg Once a Day

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: 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