Clinical trial NCT00877929: Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
Official title: An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-04-08
Enrollment: 706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.


Eligibility criteria: Inclusion criteria:

1. Hypertension defined as a mean in-clinic seated cuff Systolic Blood Pressure \>150 mmHg at Visit 3 (Randomisation visit)
2. Diagnosis of Type 2 diabetes mellitus
3. =18 years of age at the date of signing the informed consent
4. Ability to stop current antihypertensive therapy without unacceptable risk to the patient (investigator's discretion)
5. Ability to provide written informed consent

Exclusion criteria:

1. Pre-menopausal women (last menstruation \<=1 year prior to start of run-in period) who:

   1. are not surgically sterile; and/or
   2. are nursing or pregnant, or
   3. are of child-bearing potential and are NOT practicing acceptable means of birth control or do NOT plan to continue practising an acceptable method throughout the study.

   The only acceptable methods of birth control are:
   * Intrauterine device (IUD);
   * Oral contraceptives (started at least three months prior to start of run-in period)
   * Implantable or injectable contraceptives and
   * Estrogen patch
2. Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
3. Known or suspected secondary hypertension (e.g., renal artery stenosis, phaeochromocytoma)
4. Mean seated Systolic Blood Pressure (SBP) =180 mm Hg and/or mean seated Diastolic Blood Pressure (DBP) =110 mm Hg during any visit of the screening and placebo run-in periods
5. Patients with Type 1 diabetes mellitus
6. Renal dysfunction as defined by the following laboratory parameters: Serum creatinine \>3.0 mg/dL (or \>265 µmol /L) or known creatinine clearance \<30 mL/min or clinical markers of severe renal impairment
7. Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney
8. Clinically relevant hypokalaemia or hyperkalaemia
9. Uncorrected sodium or volume depletion
10. Primary aldosteronism
11. Hereditary fructose intolerance
12. Biliary obstructive disorders (e.g., cholestatis) or hepatic insufficiency
13. Congestive heart failure New York Heart Academy (NYHA) functional class CHF III-IV (Refer to Appendix 10.3)
14. Contraindication to a placebo run-in period (e.g., stroke with-in the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months prior to start of run-in period)
15. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the Investigator
16. Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
17. Patients whose diabetes has not been stable and controlled for at least the past three months as defined by an HbA1C \>10%
18. Patients who have previously experienced symptoms characteristic of angioedema during treatment with Angiotensin Converting Enzyme (ACE) inhibitors or angiotensin-II receptor antagonists
19. History of drug or alcohol dependency within six months prior to signing the informed consent form
20. Concomitant administration of any medications known to affect blood pressure, except medications allowed by the protocol
21. Any investigational drug therapy within one month of signing the informed consent
22. Known hypersensitivity to any component of the study drugs (telmisartan, amlodipine, or placebo)
23. History of non-compliance or inability to comply with prescribed medications or protocol procedures
24. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine

Primary outcomes:
measure: Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
timeFrame: Baseline, week 8
Secondary outcomes:
measure: Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6
timeFrame: Baseline, week 6
measure: Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4
timeFrame: Baseline, week 4
measure: Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2
timeFrame: Baseline, week 2
measure: Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1
timeFrame: Baseline, week 1
measure: Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks
timeFrame: Baseline, week 8
measure: BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks
timeFrame: Baseline, week 6
measure: BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks
timeFrame: Baseline, week 4
measure: BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks
timeFrame: Baseline, week 2
measure: BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week
timeFrame: Baseline, week 1
measure: BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks
timeFrame: Baseline, week 8
measure: BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks
timeFrame: Baseline, week 6
measure: BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks
timeFrame: Baseline, week 4
measure: BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks
timeFrame: Baseline, week 2
measure: BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week
timeFrame: Baseline, week 1
measure: Systolic Blood Pressure (SBP) Control 140 at Eight Weeks
timeFrame: Baseline, week 8
measure: SBP Control 140 at Six Weeks
timeFrame: Baseline, week 6
measure: SBP Control 140 at Four Weeks
timeFrame: Baseline, week 4
measure: SBP Control 140 at Two Weeks
timeFrame: Baseline, week 2
measure: SBP Control 140 at One Week
timeFrame: Baseline, week 1
measure: SBP Control 130 at Eight Weeks
timeFrame: Baseline, week 8
measure: SBP Control 130 at Six Weeks
timeFrame: Baseline, week 6
measure: SBP Control 130 at Four Weeks
timeFrame: Baseline, week 4
measure: SBP Control 130 at Two Weeks
timeFrame: Baseline, week 2
measure: SBP Control 130 at One Week
timeFrame: Baseline, week 1
measure: SBP Response 140 at Eight Weeks
timeFrame: Baseline, week 8
measure: SBP Response 140 at Six Weeks
timeFrame: Baseline, week 6
measure: SBP Response 140 at Four Weeks
timeFrame: Baseline, week 4
measure: SBP Response 140 at Two Weeks
timeFrame: Baseline, week 2
measure: SBP Response 140 at One Week
timeFrame: Baseline, week 1
measure: SBP Response 130 at Eight Weeks
timeFrame: Baseline, week 8
measure: SBP Response 130 at Six Weeks
timeFrame: Baseline, week 6
measure: SBP Response 130 at Four Weeks
timeFrame: Baseline, week 4
measure: SBP Response 130 at Two Weeks
timeFrame: Baseline, week 2
measure: SBP Response 130 at One Week
timeFrame: Baseline, week 1
measure: DBP Response at Eight Weeks
timeFrame: Week 8
measure: DBP Response at Six Weeks
timeFrame: week 6
measure: DBP Response at Week Four
timeFrame: Week 4
measure: DBP Response at Week Two
timeFrame: Week 2
measure: DBP Response at Week One
timeFrame: Week 1
measure: Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: 1235.21.901 Boehringer Ingelheim Investigational Site
state: California
city: Tustin
country: United States
facility: 1235.21.907 Boehringer Ingelheim Investigational Site
state: California
city: Fort Lauderdale
country: United States
facility: 1235.21.913 Boehringer Ingelheim Investigational Site
state: Florida
city: Hollywood
country: United States
facility: 1235.21.910 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 1235.21.903 Boehringer Ingelheim Investigational Site
state: Florida
city: Tucker
country: United States
facility: 1235.21.905 Boehringer Ingelheim Investigational Site
state: Georgia
city: Olive Branch
country: United States
facility: 1235.21.916 Boehringer Ingelheim Investigational Site
state: Mississippi
city: Hickory
country: United States
facility: 1235.21.915 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1235.21.906 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: 1235.21.902 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Penndel
country: United States
facility: 1235.21.904 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Carrollton
country: United States
facility: 1235.21.908 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 1235.21.909 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 1235.21.912 Boehringer Ingelheim Investigational Site
state: Texas
city: Ettrick
country: United States
facility: 1235.21.911 Boehringer Ingelheim Investigational Site
state: Virginia
city: Capital Federal
country: Argentina
facility: 1235.21.102 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1235.21.103 Boehringer Ingelheim Investigational Site
city: Ramos Mejía
country: Argentina
facility: 1235.21.107 Boehringer Ingelheim Investigational Site
city: Santa Fe
country: Argentina
facility: 1235.21.101 Boehringer Ingelheim Investigational Site
city: Zárate
country: Argentina
facility: 1235.21.105 Boehringer Ingelheim Investigational Site
city: Incheon
country: Korea, Republic of
facility: 1235.21.202 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.21.201 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.21.203 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.21.204 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1235.21.205 Boehringer Ingelheim Investigational Site
city: Acapulco
country: Mexico
facility: 1235.21.302 Boehringer Ingelheim Investigational Site
city: Aguascalientes
country: Mexico
facility: 1235.21.304 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1235.21.301 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1235.21.303 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1235.21.305 Boehringer Ingelheim Investigational Site
city: Guadalajara
country: Mexico
facility: 1235.21.306 Boehringer Ingelheim Investigational Site
city: Beek en Donk
country: Netherlands
facility: 1235.21.408 Boehringer Ingelheim Investigational Site
city: Den Haag
country: Netherlands
facility: 1235.21.406 Boehringer Ingelheim Investigational Site
city: Hoogwoud
country: Netherlands
facility: 1235.21.401 Boehringer Ingelheim Investigational Site
city: Musselkanaal
country: Netherlands
facility: 1235.21.405 Boehringer Ingelheim Investigational Site
city: Nijverdal
country: Netherlands
facility: 1235.21.404 Boehringer Ingelheim Investigational Site
city: Oude Pekela
country: Netherlands
facility: 1235.21.403 Boehringer Ingelheim Investigational Site
city: Roelofarensveen
country: Netherlands
facility: 1235.21.409 Boehringer Ingelheim Investigational Site
city: Voerendaal
country: Netherlands
facility: 1235.21.407 Boehringer Ingelheim Investigational Site
city: Wildervank
country: Netherlands
facility: 1235.21.402 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1235.21.501 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1235.21.502 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1235.21.503 Boehringer Ingelheim Investigational Site
city: Bratislava
country: Slovakia
facility: 1235.21.504 Boehringer Ingelheim Investigational Site
city: Dunajska Streda
country: Slovakia
facility: 1235.21.507 Boehringer Ingelheim Investigational Site
city: Martin
country: Slovakia
facility: 1235.21.509 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1235.21.505 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1235.21.506 Boehringer Ingelheim Investigational Site
city: Rimavska Sobota
country: Slovakia
facility: 1235.21.508 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.21.27005 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1235.21.27007 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1235.21.27004 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1235.21.27006 Boehringer Ingelheim Investigational Site
city: Krugersdorp
country: South Africa
facility: 1235.21.27002 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 1235.21.27001 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1235.21.27003 Boehringer Ingelheim Investigational Site
city: Castellón
country: Spain
facility: 1235.21.702 Boehringer Ingelheim Investigational Site
city: Centelles
country: Spain
facility: 1235.21.705 Boehringer Ingelheim Investigational Site
city: Sant Adrià del Besós
country: Spain
facility: 1235.21.703 Boehringer Ingelheim Investigational Site
city: Santa Coloma de Gramanet (Barcelona)
country: Spain
facility: 1235.21.704 Boehringer Ingelheim Investigational Site
city: Santa Coloma de Gramanet
country: Spain
facility: 1235.21.706 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1235.21.801 Boehringer Ingelheim Investigational Site
city: Helsingborg
country: Sweden
facility: 1235.21.803 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1235.21.804 Boehringer Ingelheim Investigational Site
city: Västerås
country: Sweden
facility: 1235.21.802 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: