Clinical trial NCT01134393: TElmisartan and AMlodipine Single Pill sTudy With Patients Not on Goal With Mono rAas Therapy-switch
Official title: A Prospective, Open-label TElmisartan/AMlodipine Single Pill STudy to Assess the Efficacy in Patients With Essential Hypertension"..."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-02
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Study Design:

Eligibility criteria: 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 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

Exclusion criteria:

1. 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.
2. Known or suspected secondary hypertension (e.g., renal artery stenosis or phaeochromocytoma).
3. 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.
4. 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.
5. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
6. Clinically relevant hypokalaemia or hyperkalaemia (i.e., \<3.5 or \>5.5 mEq/L).
7. Uncorrected sodium or volume depletion.
8. Primary aldosteronism.
9. Hereditary fructose intolerance.
10. Congestive heart failure New York Heart Association functional class Congestive Heart Failure III-IV (Refer to Appendix 10.1).
11. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator.
12. 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)
13. Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists.
14. History of drug or alcohol dependency within six months prior to signing the informed consent form.
15. Any investigational drug therapy within one month of signing the informed consent.
16. Known hypersensitivity to any component of the trial drugs (telmisartan or amlodipine).
17. History of non-compliance or inability to comply with prescribed medications or protocol procedures.
18. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Primary outcomes:
measure: Percentage of Patients Achieving Blood Pressure (BP) Control After 12 Weeks of Treatment Using In-clinic BP Measurements.
timeFrame: 12 weeks
Secondary outcomes:
measure: BP Control After 4 and 8 Weeks of Treatment Using In-clinic BP Measurements.
timeFrame: 4 and 8 weeks
measure: BP Control (Morning and Evening) After 12 Weeks of Treatment Using Home Blood Pressure Measurement (HBPM).
timeFrame: Week 12
measure: Change From Baseline Over Time in In-clinic Measured Mean SBP and Mean DBP
timeFrame: weeks 4, 8 and 12
measure: Change From Baseline Over Time in In-clinic Measured Mean Pulse Rate
timeFrame: weeks 4, 8 and 12
measure: Change From Baseline Over Time in In-clinic Measured Mean Pulse Pressure
timeFrame: weeks 4, 8 and 12
measure: DBP and SBP Control and Response Rates After 4, 8 and 12 Weeks of Treatment Using In-clinic BP Measurements
timeFrame: weeks 4, 8 and 12
measure: Percentage of Patients in Blood Pressure Categories Over Time
timeFrame: weeks 4, 8 and 12
measure: DBP and SBP Control and Response Rates Morning and Evening Over Time HBPM Measurements
timeFrame: weeks 4, 8 and 12
measure: Frequency of Patients Requiring Up-titration to Telmisartan 80mg Plus Amlodipine 10mg Combination (T80/A10) to Achieve Blood Pressure Control Over Time
timeFrame: weeks 4 and 8
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 1235.33.49010 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1235.33.49002 Boehringer Ingelheim Investigational Site
city: Haag
country: Germany
facility: 1235.33.49007 Boehringer Ingelheim Investigational Site
city: Heidelberg
country: Germany
facility: 1235.33.49003 Boehringer Ingelheim Investigational Site
city: Künzing
country: Germany
facility: 1235.33.49005 Boehringer Ingelheim Investigational Site
city: Nürnberg
country: Germany
facility: 1235.33.49008 Boehringer Ingelheim Investigational Site
city: Rednitzhembach
country: Germany
facility: 1235.33.49009 Boehringer Ingelheim Investigational Site
city: Rodgau-Dudenhofen
country: Germany
facility: 1235.33.49006 Boehringer Ingelheim Investigational Site
city: Unterschneidheim
country: Germany
facility: 1235.33.49004 Boehringer Ingelheim Investigational Site
city: Westerkappeln
country: Germany
facility: 1235.33.49001 Boehringer Ingelheim Investigational Site
city: Arezzo
country: Italy
facility: 1235.33.39009 Boehringer Ingelheim Investigational Site
city: Bologna
country: Italy
facility: 1235.33.39002 Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: 1235.33.39004 Boehringer Ingelheim Investigational Site
city: L'Aquila
country: Italy
facility: 1235.33.39006 Boehringer Ingelheim Investigational Site
city: Napoli
country: Italy
facility: 1235.33.39007 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1235.33.39001 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1235.33.39008 Boehringer Ingelheim Investigational Site
city: Stradella (PV)
country: Italy
facility: 1235.33.39005 Boehringer Ingelheim Investigational Site
city: Aguascalientes
country: Mexico
facility: 1235.33.52004 Boehringer Ingelheim Investigational Site
city: Durango
country: Mexico
facility: 1235.33.52002 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1235.33.52001 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1235.33.52003 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1235.33.52007 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1235.33.52006 Boehringer Ingelheim Investigational Site
city: Mexico
country: Mexico
facility: 1235.33.52009 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1235.33.52008 Boehringer Ingelheim Investigational Site
city: 's Hertogenbosch
country: Netherlands
facility: 1235.33.31007 Boehringer Ingelheim Investigational Site
city: Almere
country: Netherlands
facility: 1235.33.31009 Boehringer Ingelheim Investigational Site
city: Beek en Donk
country: Netherlands
facility: 1235.33.31005 Boehringer Ingelheim Investigational Site
city: Beerzerveld
country: Netherlands
facility: 1235.33.31002 Boehringer Ingelheim Investigational Site
city: Ermelo
country: Netherlands
facility: 1235.33.31008 Boehringer Ingelheim Investigational Site
city: Lichtenvoorde
country: Netherlands
facility: 1235.33.31006 Boehringer Ingelheim Investigational Site
city: Musselkanaal
country: Netherlands
facility: 1235.33.31001 Boehringer Ingelheim Investigational Site
city: Nijverdal
country: Netherlands
facility: 1235.33.31004 Boehringer Ingelheim Investigational Site
city: Wildervank
country: Netherlands
facility: 1235.33.31003 Boehringer Ingelheim Investigational Site
city: Chorzow
country: Poland
facility: 1235.33.48005 Boehringer Ingelheim Investigational Site
city: Czestochowa
country: Poland
facility: 1235.33.48002 Boehringer Ingelheim Investigational Site
city: Czestochowa
country: Poland
facility: 1235.33.48003 Boehringer Ingelheim Investigational Site
city: Dabrowa Gornicza
country: Poland
facility: 1235.33.48010 Boehringer Ingelheim Investigational Site
city: Grodzisk Mazowiecki
country: Poland
facility: 1235.33.48006 Boehringer Ingelheim Investigational Site
city: Oswiecim
country: Poland
facility: 1235.33.48013 Boehringer Ingelheim Investigational Site
city: Piotrkow Trybunalski
country: Poland
facility: 1235.33.48008 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 1235.33.48004 Boehringer Ingelheim Investigational Site
city: Tychy
country: Poland
facility: 1235.33.48001 Boehringer Ingelheim Investigational Site
city: Tychy
country: Poland
facility: 1235.33.48009 Boehringer Ingelheim Investigational Site
city: Warszawa
country: Poland
facility: 1235.33.48011 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1235.33.48007 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: