Telmisartan and Amlodipine Fixed Dose Combination [FDC] Trial for the Treatment of Severe Hypertension

Boehringer Ingelheim858 enrolled

Overview

The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure \[SBP\] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

858

Conditions

Hypertension

Interventions

amlodipineDRUG

amlodipine 5mg for the first 2w then force titration to Amlodipine 10mg for remaining 6 w

telmisartanDRUG

telmisartan 80mg for the 8w, no titration required

telmisartan and amlodipineDRUG

telmisartan 80 and amlodipine 5mg for the first 2 weeks, then force titrated to telmisartan 80mg and amlodipine 10mg for the remaining 6w

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation 2. Age 18 years or older 3. Patients with severe hypertension as defined SBP greater than 180 mmHg and DBP greater than 95 mmHg at randomisation 4. Ability to stop any current antihypertensive therapy without unacceptable risk to the patient (Investigators discretion) Exclusion criteria Mean in-clinic seated cuff SBP \>/= 200 mmHg and/or Diastolic Blood Pressure \[DBP\] \>/= 95 mmHg

Locations (137)

Outcomes

Primary Outcomes

Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8

Overall mean reduction from a common mean baseline in SBP

Time frame: baseline and week 8

Secondary Outcomes

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6

Overall mean reduction from a common mean baseline in SBP

Time frame: baseline and week 6

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4

Overall mean reduction from a common mean baseline in SBP

Time frame: baseline and week 4

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2

Overall mean reduction from a common mean baseline in SBP

Time frame: baseline and week 2

Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1

Overall mean reduction from a common mean baseline in SBP

Time frame: baseline and week 1

Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8

Overall mean reduction from a common mean baseline in DBP

Time frame: baseline and week 8

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6

Overall mean reduction from a common mean baseline in DBP

Time frame: baseline and week 6

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4

Data from ClinicalTrials.gov

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1235.20.525 Boehringer Ingelheim Investigational Site

Buena Park, California, United States

1235.20.503 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

1235.20.507 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

1235.20.529 Boehringer Ingelheim Investigational Site

Roseville, California, United States

1235.20.518 Boehringer Ingelheim Investigational Site

Tustin, California, United States

1235.20.521 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

1235.20.508 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

1235.20.506 Boehringer Ingelheim Investigational Site

Hialeah, Florida, United States

1235.20.519 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

1235.20.523 Boehringer Ingelheim Investigational Site

Port Orange, Florida, United States

...and 127 more locations

Overall mean reduction from a common mean baseline in DBP

Time frame: baseline and week 4

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2

Overall mean reduction from a common mean baseline in DBP

Time frame: baseline and week 2

Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1

Overall mean reduction from a common mean baseline in DBP

Time frame: baseline and week 1

Patients Achieving Diastolic Blood Pressure Control at Week 1

Diastolic Blood Pressure Control is defined as achieving DBP \< 90mmHg

Time frame: week 1

Patients Achieving Diastolic Blood Pressure Control at Week 2

DBP \< 90 mmHg

Time frame: week 2

Patients Achieving Blood Pressure Control at Week 1

Blood Pressure Control is defined as achieving SBP\< 140 mmHg and DBP \< 90mmHg

Time frame: week 1

Patients Achieving Blood Pressure Control at Week 2

SBP \< 140 mmHg and DBP \< 90 mmHg

Time frame: week 2

Patients Achieving Diastolic Blood Pressure Response at Week 1

Diastolic Blood Pressure Response is defined as achieving DBP \< 90 mmHg or a reduction of \>= 10 mmHg

Time frame: baseline, week 1

Patients Achieving Diastolic Blood Pressure Response at Week 2

DBP \< 90 mmHg or reduction of \>= 10 mmHg

Time frame: baseline, week 2

Patients Achieving Systolic Blood Pressure Response at Week 1

Systolic Blood Pressure Response Control is defined as achieving SBP \< 140 mmHg or a reduction of \>= 15 mmHg

Time frame: baseline, week 1

Patients Achieving Systolic Blood Pressure Response at Week 2

SBP \< 140 mmHg or reduction of \>= 15 mmHg

Time frame: baseline, week 2

Number of Patients Achieving Various Blood Pressure Response Levels at Week 1

Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90

Time frame: week 1

Number of Patients Achieving Various Blood Pressure Response Levels at Week 2

Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90

Time frame: week 2

Patients Achieving Diastolic Blood Pressure Control at Week 4

DBP \< 90 mmHg

Time frame: week 4

Patients Achieving Diastolic Blood Pressure Control at Week 6

DBP \< 90 mmHg

Time frame: week 6

Patients Achieving Diastolic Blood Pressure Control at Week 8

DBP \< 90 mmHg

Time frame: week 8

Patients Achieving Blood Pressure Control at Week 4

SBP \< 140 mmHg and DBP \< 90 mmHg

Time frame: week 4

Patients Achieving Blood Pressure Control at Week 6

SBP \< 140 mmHg and DBP \< 90 mmHg

Time frame: week 6

Patients Achieving Blood Pressure Control at Week 8

SBP \< 140 mmHg and DBP \< 90 mmHg

Time frame: week 8

Patients Achieving Diastolic Blood Pressure Response at Week 4

DBP \< 90 mmHg or reduction of \>= 10 mmHg

Time frame: baseline, week 4

Patients Achieving Diastolic Blood Pressure Response at Week 6

DBP \< 90 mmHg or reduction of \>= 10 mmHg

Time frame: baseline, week 6

Patients Achieving Diastolic Blood Pressure Response at Week 8

DBP \< 90 mmHg or reduction of \>= 10 mmHg

Time frame: baseline, week 8

Patients Achieving Systolic Blood Pressure Response at Week 4

SBP \< 140 mmHg or reduction of \>= 15 mmHg

Time frame: baseline, week 4

Patients Achieving Systolic Blood Pressure Response at Week 6

SBP \< 140 mmHg or reduction of \>= 15 mmHg

Time frame: baseline, week 6

Patients Achieving Systolic Blood Pressure Response at Week 8

SBP \< 140 mmHg or reduction of \>= 15 mmHg

Time frame: baseline, week 8

Patients Achieving Normal Blood Pressure Response at Week 4

Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90

Time frame: week 4

Patients Achieving Normal Blood Pressure Response at Week 6

Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90

Time frame: week 6

Patients Achieving Normal Blood Pressure Response at Week 8

Optimal: SBP\<120 and DBP\< 80; Normal: 120\<=SBP\<130 and 80\<= DBP\<85; High normal: 130\<=SBP\<140 and 85\<=DBP\<90; High: SBP\>=140 or DBP\>=90

Time frame: week 8