TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch

NCT01134393 | Completed Phase 3 Results

• 2 other identifiers: 1235.332009-017336-40
• Study Type: interventional
• Target: 502
• Locations: 5 countries
• Sites: 47

Brief Summary

The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.

  Achieving BP control is defined as SBP\<140 mmHg and DBP\<90 mmHg.

  12 weeks

Secondary Outcomes (9)

• BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.

  4 and 8 weeks

• BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).

  Week 12

• Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP

  weeks 4, 8 and 12

• Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate

  weeks 4, 8 and 12

• Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure

  weeks 4, 8 and 12

Study Arms (1)

telmisartan/amlodipine

EXPERIMENTAL

start low dose and uptitrate to high dose on the basis of blood pressure goal

Drug: telmisartan/amlodipine

Interventions

telmisartan/amlodipine DRUG

start low dose and uptitrate to high dose on the basis of BP goal

telmisartan/amlodipine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation
• Age 18 years or older
• Patients with uncontrolled hypertension as defined SBP \> 140 mmHg and SBP \> 130 mmHg in patients with diabetes or renal impairment or DBP \> 90 mmHg and DBP \>80 mmHg in patients with diabetes or renal impairment after at least an 6 weeks of stable treatment with antihypertensive medication defined as treatment with the clinically recommended dose of a single RAAS blocking agent (Angiotensin Converting Enzym inhibition, AII Receptor Blocker and Direct Renin Inhibitor) at entering the trial. Renal impairment is defined as a creatinine \>133µmol/l (1.5mg/dl) in male patients and a creatinine \>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min

You may not qualify if:

• Pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study and do not agree to submit to pregnancy testing during participation in the trial. Acceptable methods of birth control include the transdermal patch, oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner.
• Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma).
• Mean in-clinic seated cuff Systolic BP \>180 mmHg and SBP \>160 mmHg in patients with diabetes or renal impairment or Diastolic BP \>110 mmHg and DBP \>100 mmHg in patients with diabetes or renal impairment. Renal impairment is defined as a creatinine \>133µmol/l (1.5mg/dl) in male patients and a creatinine \>124µmol/l (1.3mg/dl) in female patients or a creatinine clearance between 30-60 ml/min.
• Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dl (or \>265 ¿mol/L) and/or known creatinine clearance of \<30 ml/min and/or clinical markers of severe renal impairment.
• Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
• Clinically relevant hypokalaemia or hyperkalaemia (i.e., \<3.5 or \>5.5 mEq/L).
• Uncorrected sodium or volume depletion.
• Primary aldosteronism.
• Hereditary fructose intolerance.
• Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1).
• Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.
• Biliary obstructive disorders (e.g., cholestasis) or hepatic insufficiency (defined as elevated levels of \>2x bilirubin or \>2x transaminases values). (Refer to Appendix 10.3)
• Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists.
• History of drug or alcohol dependency within six months prior to signing the informed consent form.
• Any investigational drug therapy within one month of signing the informed consent.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (47)

1235.33.49010 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1235.33.49002 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1235.33.49007 Boehringer Ingelheim Investigational Site

Haag, Germany

Location

1235.33.49003 Boehringer Ingelheim Investigational Site

Heidelberg, Germany

Location

1235.33.49005 Boehringer Ingelheim Investigational Site

Künzing, Germany

Location

1235.33.49008 Boehringer Ingelheim Investigational Site

Nuremberg, Germany

Location

1235.33.49009 Boehringer Ingelheim Investigational Site

Rednitzhembach, Germany

Location

1235.33.49006 Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, Germany

Location

1235.33.49004 Boehringer Ingelheim Investigational Site

Unterschneidheim, Germany

Location

1235.33.49001 Boehringer Ingelheim Investigational Site

Westerkappeln, Germany

Location

1235.33.39009 Boehringer Ingelheim Investigational Site

Arezzo, Italy

Location

1235.33.39002 Boehringer Ingelheim Investigational Site

Bologna, Italy

Location

1235.33.39004 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

1235.33.39006 Boehringer Ingelheim Investigational Site

L’Aquila, Italy

Location

1235.33.39007 Boehringer Ingelheim Investigational Site

Napoli, Italy

Location

1235.33.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1235.33.39008 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1235.33.39005 Boehringer Ingelheim Investigational Site

Stradella (PV), Italy

Location

1235.33.52004 Boehringer Ingelheim Investigational Site

Aguascalientes, Mexico

Location

1235.33.52002 Boehringer Ingelheim Investigational Site

Durango, Mexico

Location

1235.33.52001 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1235.33.52003 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1235.33.52007 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1235.33.52006 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1235.33.52009 Boehringer Ingelheim Investigational Site

México, Mexico

Location

1235.33.52008 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1235.33.31007 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1235.33.31009 Boehringer Ingelheim Investigational Site

Almere Stad, Netherlands

Location

1235.33.31005 Boehringer Ingelheim Investigational Site

Beek en Donk, Netherlands

Location

1235.33.31002 Boehringer Ingelheim Investigational Site

Beerzerveld, Netherlands

Location

1235.33.31008 Boehringer Ingelheim Investigational Site

Ermelo, Netherlands

Location

1235.33.31006 Boehringer Ingelheim Investigational Site

Lichtenvoorde, Netherlands

Location

1235.33.31001 Boehringer Ingelheim Investigational Site

Musselkanaal, Netherlands

Location

1235.33.31004 Boehringer Ingelheim Investigational Site

Nijverdal, Netherlands

Location

1235.33.31003 Boehringer Ingelheim Investigational Site

Wildervank, Netherlands

Location

1235.33.48005 Boehringer Ingelheim Investigational Site

Chorzów, Poland

Location

1235.33.48002 Boehringer Ingelheim Investigational Site

Częstochowa, Poland

Location

1235.33.48003 Boehringer Ingelheim Investigational Site

Częstochowa, Poland

Location

1235.33.48010 Boehringer Ingelheim Investigational Site

Dąbrowa Górnicza, Poland

Location

1235.33.48006 Boehringer Ingelheim Investigational Site

Grodzisk Mazowiecki, Poland

Location

1235.33.48013 Boehringer Ingelheim Investigational Site

Oświęcim, Poland

Location

1235.33.48008 Boehringer Ingelheim Investigational Site

Piotrkow Trybunalski, Poland

Location

1235.33.48004 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1235.33.48001 Boehringer Ingelheim Investigational Site

Tychy, Poland

Location

1235.33.48009 Boehringer Ingelheim Investigational Site

Tychy, Poland

Location

1235.33.48011 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1235.33.48007 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

Location

MeSH Terms

Conditions

Hypertension

Interventions

telmisartan amlodipine combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Last Updated: January 15, 2014
• Results First Posted: July 4, 2012

Record last verified: 2013-12

Locations

DE (10); IT (8); PL (12); ME (8); NL (9)