Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus

Condition(s) targeted: Hypertension

Intervention: Telmisartan 80 (Drug); Amlodipine 10 (Drug); Amlodipine 10 (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Boehringer Ingelheim

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim

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

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8

Secondary outcome:

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

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

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

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

Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks

BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks

BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks

BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks

BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week

Systolic Blood Pressure (SBP) Control 140 at Eight Weeks

SBP Control 140 at Six Weeks

SBP Control 140 at Four Weeks

SBP Control 140 at Two Weeks

SBP Control 140 at One Week

SBP Control 130 at Eight Weeks

SBP Control 130 at Six Weeks

SBP Control 130 at Four Weeks

SBP Control 130 at Two Weeks

SBP Control 130 at One Week

SBP Response 140 at Eight Weeks

SBP Response 140 at Six Weeks

SBP Response 140 at Four Weeks

SBP Response 140 at Two Weeks

SBP Response 140 at One Week

SBP Response 130 at Eight Weeks

SBP Response 130 at Six Weeks

SBP Response 130 at Four Weeks

SBP Response 130 at Two Weeks

SBP Response 130 at One Week

DBP Response at Eight Weeks

DBP Response at Six Weeks

DBP Response at Week Four

DBP Response at Week Two

DBP Response at Week One

Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

1235.21.102 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina

1235.21.103 Boehringer Ingelheim Investigational Site, Capital Federal, Argentina

1235.21.107 Boehringer Ingelheim Investigational Site, Ramos Mejía, Argentina

1235.21.101 Boehringer Ingelheim Investigational Site, Santa Fe, Argentina

1235.21.105 Boehringer Ingelheim Investigational Site, Zárate, Argentina

1235.21.202 Boehringer Ingelheim Investigational Site, Incheon, Korea, Republic of

1235.21.201 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1235.21.203 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1235.21.204 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1235.21.205 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

1235.21.302 Boehringer Ingelheim Investigational Site, Acapulco, Mexico

1235.21.304 Boehringer Ingelheim Investigational Site, Aguascalientes, Mexico

1235.21.301 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico

1235.21.303 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico

1235.21.305 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico

1235.21.306 Boehringer Ingelheim Investigational Site, Guadalajara, Mexico

1235.21.408 Boehringer Ingelheim Investigational Site, Beek en Donk, Netherlands

1235.21.406 Boehringer Ingelheim Investigational Site, Den Haag, Netherlands

1235.21.401 Boehringer Ingelheim Investigational Site, Hoogwoud, Netherlands

1235.21.405 Boehringer Ingelheim Investigational Site, Musselkanaal, Netherlands

1235.21.404 Boehringer Ingelheim Investigational Site, Nijverdal, Netherlands

1235.21.403 Boehringer Ingelheim Investigational Site, Oude Pekela, Netherlands

1235.21.409 Boehringer Ingelheim Investigational Site, Roelofarensveen, Netherlands

1235.21.407 Boehringer Ingelheim Investigational Site, Voerendaal, Netherlands

1235.21.402 Boehringer Ingelheim Investigational Site, Wildervank, Netherlands

1235.21.501 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1235.21.502 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1235.21.503 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1235.21.504 Boehringer Ingelheim Investigational Site, Bratislava, Slovakia

1235.21.507 Boehringer Ingelheim Investigational Site, Dunajska Streda, Slovakia

1235.21.509 Boehringer Ingelheim Investigational Site, Martin, Slovakia

1235.21.505 Boehringer Ingelheim Investigational Site, Nitra, Slovakia

1235.21.506 Boehringer Ingelheim Investigational Site, Nitra, Slovakia

1235.21.508 Boehringer Ingelheim Investigational Site, Rimavska Sobota, Slovakia

1235.21.27005 Boehringer Ingelheim Investigational Site, Cape Town, South Africa

1235.21.27007 Boehringer Ingelheim Investigational Site, Cape Town, South Africa

1235.21.27004 Boehringer Ingelheim Investigational Site, Durban, South Africa

1235.21.27006 Boehringer Ingelheim Investigational Site, Johannesburg, South Africa

1235.21.27002 Boehringer Ingelheim Investigational Site, Krugersdorp, South Africa

1235.21.27001 Boehringer Ingelheim Investigational Site, Lenasia, South Africa

1235.21.27003 Boehringer Ingelheim Investigational Site, Pretoria, South Africa

1235.21.702 Boehringer Ingelheim Investigational Site, Castellón, Spain

1235.21.705 Boehringer Ingelheim Investigational Site, Centelles, Spain

1235.21.703 Boehringer Ingelheim Investigational Site, Sant Adrià del Besós, Spain

1235.21.704 Boehringer Ingelheim Investigational Site, Santa Coloma de Gramanet (Barcelona), Spain

1235.21.706 Boehringer Ingelheim Investigational Site, Santa Coloma de Gramanet, Spain

1235.21.801 Boehringer Ingelheim Investigational Site, Göteborg, Sweden

1235.21.803 Boehringer Ingelheim Investigational Site, Helsingborg, Sweden

1235.21.804 Boehringer Ingelheim Investigational Site, Lund, Sweden

1235.21.802 Boehringer Ingelheim Investigational Site, Västerås, Sweden

1235.21.901 Boehringer Ingelheim Investigational Site, Long Beach, California, United States

1235.21.907 Boehringer Ingelheim Investigational Site, Tustin, California, United States

1235.21.913 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States

1235.21.910 Boehringer Ingelheim Investigational Site, Hollywood, Florida, United States

1235.21.903 Boehringer Ingelheim Investigational Site, Pembroke Pines, Florida, United States

1235.21.905 Boehringer Ingelheim Investigational Site, Tucker, Georgia, United States

1235.21.916 Boehringer Ingelheim Investigational Site, Olive Branch, Mississippi, United States

1235.21.915 Boehringer Ingelheim Investigational Site, Hickory, North Carolina, United States

1235.21.906 Boehringer Ingelheim Investigational Site, Winston-Salem, North Carolina, United States

1235.21.902 Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

1235.21.904 Boehringer Ingelheim Investigational Site, Penndel, Pennsylvania, United States

1235.21.908 Boehringer Ingelheim Investigational Site, Carrollton, Texas, United States

1235.21.909 Boehringer Ingelheim Investigational Site, Dallas, Texas, United States

1235.21.912 Boehringer Ingelheim Investigational Site, Killeen, Texas, United States

1235.21.911 Boehringer Ingelheim Investigational Site, Ettrick, Virginia, United States

Starting date: February 2009
Last updated: February 10, 2014