Trial Outcomes & Findings for Telmisartan Tab Hypertension (NCT NCT00890084)

NCT ID: NCT00890084

Last Updated: 2014-04-08

Results Overview

% of high risk patients with Blood Pressure \< 140/90 mm Hg

• Recruitment status: COMPLETED
• Target enrollment: 2913 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-04-08

Participant Flow

April 1st 2009 to January 1st 2010 recruited in 90.5% General Practitioners (GP's) and 9.5% Specialists (Sp's)

45 patients excluded for inclusion/exclusion criteria

Participant milestones

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Overall Study STARTED	2913
Overall Study COMPLETED	2771
Overall Study NOT COMPLETED	142

Reasons for withdrawal

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Overall Study Adverse Event	16
Overall Study Lost to Follow-up	126

Baseline Characteristics

Telmisartan Tab Hypertension

Baseline characteristics by cohort

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2913 Participants
Age, Customized	64.4 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex/Gender, Customized Female	48.8 percentage of participants n=5 Participants
Sex/Gender, Customized Male	51.2 percentage of participants n=5 Participants
Systolic and diastolic blood pressure Systolic Blood Pressure	156.1 mm Hg STANDARD_DEVIATION 12.9 • n=5 Participants
Systolic and diastolic blood pressure Diastolic Blood Pressure	91.9 mm Hg STANDARD_DEVIATION 8.64 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Intention-to-Treat (ITT)

% of high risk patients with Blood Pressure < 140/90 mm Hg

Outcome measures

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2771 Participants
Percentage of Patients With Blood Pressure < 140/90 mm Hg	69.6 Percentage of participants Interval 67.9 to 71.3

SECONDARY outcome

Timeframe: 12 weeks

Population: Intention to Treat (ITT)

Outcome measures

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2771 Participants
Percentage of Patients With Blood Pressure < 130/80 mm Hg	13.2 Percentage of participants Interval 12.0 to 14.5

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Intention to treat (ITT)

systolic blood pressure

Outcome measures

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2771 Participants
Absolute Blood Pressure Decrease	23.2 mm Hg Interval 22.7 to 23.7

SECONDARY outcome

Timeframe: 12 weeks

Population: ITT Population

BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)

Outcome measures

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2771 Participants
BP Response Rate (Drop of Systolic BP of 10mmHg or More)	91.85 Percentage of patients Interval 90.8 to 92.6

SECONDARY outcome

Timeframe: 12 weeks

Population: ITT Population

Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications).

Outcome measures

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2771 Participants
Treatment Patterns Telmisartan 40mg	4.7 Percentage of patients
Treatment Patterns Telmisartan 80mg	49.4 Percentage of patients
Treatment Patterns Telmisartan 40/12,5mg	3.3 Percentage of patients
Treatment Patterns Telmisartan 80/12,5mg	29.7 Percentage of patients
Treatment Patterns Telmisartan 80/25mg	12.6 Percentage of patients

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Intention to treat (ITT)

Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not.

Outcome measures

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2771 Participants
Change in Concomitant Antihypertensive Drugs Given at Study Entry	13.6 percentage of patients Interval 12.3 to 14.9

SECONDARY outcome

Timeframe: 12 weeks

Population: Intention to treat (ITT)

Outcome measures

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2771 Participants
Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg	11.7 percentage of patients Interval 10.5 to 12.9

SECONDARY outcome

Timeframe: 12 weeks

Population: all investigators participating in the trial

Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients

Outcome measures

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=432 Participants
Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007	47.7 percentage of prescribers Interval 43.0 to 52.4

Adverse Events

Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) n=2771 participants at risk
Gastrointestinal disorders Umbilical hernia	0.04% 1/2771 • 12 weeks solicited reporting
Surgical and medical procedures Alcohol detoxification	0.04% 1/2771 • 12 weeks solicited reporting
Vascular disorders cerebral hemorrhage, fatal	0.04% 1/2771 • 12 weeks solicited reporting

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 Other - 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