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

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.

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Telmisartan 80; Drug: Amlodipine 10

• Study Type: Interventional
• Enrollment (Actual): 706
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Capital Federal, Argentina
    • 1235.21.102 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1235.21.103 Boehringer Ingelheim Investigational Site
  • Ramos Mejía, Argentina
    • 1235.21.107 Boehringer Ingelheim Investigational Site
  • Santa Fe, Argentina
    • 1235.21.101 Boehringer Ingelheim Investigational Site
  • Zárate, Argentina
    • 1235.21.105 Boehringer Ingelheim Investigational Site
• Korea, Republic of
  • Incheon, Korea, Republic of
    • 1235.21.202 Boehringer Ingelheim Investigational Site
  • Seoul, 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
• Mexico
  • Acapulco, Mexico
    • 1235.21.302 Boehringer Ingelheim Investigational Site
  • Aguascalientes, Mexico
    • 1235.21.304 Boehringer Ingelheim Investigational Site
  • Guadalajara, 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
• Netherlands
  • Beek en Donk, Netherlands
    • 1235.21.408 Boehringer Ingelheim Investigational Site
  • Den Haag, Netherlands
    • 1235.21.406 Boehringer Ingelheim Investigational Site
  • Hoogwoud, Netherlands
    • 1235.21.401 Boehringer Ingelheim Investigational Site
  • Musselkanaal, Netherlands
    • 1235.21.405 Boehringer Ingelheim Investigational Site
  • Nijverdal, Netherlands
    • 1235.21.404 Boehringer Ingelheim Investigational Site
  • Oude Pekela, Netherlands
    • 1235.21.403 Boehringer Ingelheim Investigational Site
  • Roelofarensveen, Netherlands
    • 1235.21.409 Boehringer Ingelheim Investigational Site
  • Voerendaal, Netherlands
    • 1235.21.407 Boehringer Ingelheim Investigational Site
  • Wildervank, Netherlands
    • 1235.21.402 Boehringer Ingelheim Investigational Site
• Slovakia
  • Bratislava, Slovakia
    • 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
  • Dunajska Streda, Slovakia
    • 1235.21.507 Boehringer Ingelheim Investigational Site
  • Martin, Slovakia
    • 1235.21.509 Boehringer Ingelheim Investigational Site
  • Nitra, Slovakia
    • 1235.21.505 Boehringer Ingelheim Investigational Site
  • Nitra, Slovakia
    • 1235.21.506 Boehringer Ingelheim Investigational Site
  • Rimavska Sobota, Slovakia
    • 1235.21.508 Boehringer Ingelheim Investigational Site
• South Africa
  • Cape Town, South Africa
    • 1235.21.27005 Boehringer Ingelheim Investigational Site
  • Cape Town, South Africa
    • 1235.21.27007 Boehringer Ingelheim Investigational Site
  • Durban, South Africa
    • 1235.21.27004 Boehringer Ingelheim Investigational Site
  • Johannesburg, South Africa
    • 1235.21.27006 Boehringer Ingelheim Investigational Site
  • Krugersdorp, South Africa
    • 1235.21.27002 Boehringer Ingelheim Investigational Site
  • Lenasia, South Africa
    • 1235.21.27001 Boehringer Ingelheim Investigational Site
  • Pretoria, South Africa
    • 1235.21.27003 Boehringer Ingelheim Investigational Site
• Spain
  • Castellón, Spain
    • 1235.21.702 Boehringer Ingelheim Investigational Site
  • Centelles, Spain
    • 1235.21.705 Boehringer Ingelheim Investigational Site
  • Sant Adrià del Besós, Spain
    • 1235.21.703 Boehringer Ingelheim Investigational Site
  • Santa Coloma de Gramanet, Spain
    • 1235.21.706 Boehringer Ingelheim Investigational Site
  • Santa Coloma de Gramanet (Barcelona), Spain
    • 1235.21.704 Boehringer Ingelheim Investigational Site
• Sweden
  • Göteborg, Sweden
    • 1235.21.801 Boehringer Ingelheim Investigational Site
  • Helsingborg, Sweden
    • 1235.21.803 Boehringer Ingelheim Investigational Site
  • Lund, Sweden
    • 1235.21.804 Boehringer Ingelheim Investigational Site
  • Västerås, Sweden
    • 1235.21.802 Boehringer Ingelheim Investigational Site
• United States
  • California
    • Long Beach, California, United States
      • 1235.21.901 Boehringer Ingelheim Investigational Site
    • Tustin, California, United States
      • 1235.21.907 Boehringer Ingelheim Investigational Site
  • Florida
    • Fort Lauderdale, Florida, United States
      • 1235.21.913 Boehringer Ingelheim Investigational Site
    • Hollywood, Florida, United States
      • 1235.21.910 Boehringer Ingelheim Investigational Site
    • Pembroke Pines, Florida, United States
      • 1235.21.903 Boehringer Ingelheim Investigational Site
  • Georgia
    • Tucker, Georgia, United States
      • 1235.21.905 Boehringer Ingelheim Investigational Site
  • Mississippi
    • Olive Branch, Mississippi, United States
      • 1235.21.916 Boehringer Ingelheim Investigational Site
  • North Carolina
    • Hickory, North Carolina, United States
      • 1235.21.915 Boehringer Ingelheim Investigational Site
    • Winston-Salem, North Carolina, United States
      • 1235.21.906 Boehringer Ingelheim Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • 1235.21.902 Boehringer Ingelheim Investigational Site
  • Pennsylvania
    • Penndel, Pennsylvania, United States
      • 1235.21.904 Boehringer Ingelheim Investigational Site
  • Texas
    • Carrollton, Texas, United States
      • 1235.21.908 Boehringer Ingelheim Investigational Site
    • Dallas, Texas, United States
      • 1235.21.909 Boehringer Ingelheim Investigational Site
    • Killeen, Texas, United States
      • 1235.21.912 Boehringer Ingelheim Investigational Site
  • Virginia
    • Ettrick, Virginia, United States
      • 1235.21.911 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telmisartan 80 / Amlodipine 10; Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination	Drug: Telmisartan 80; Telmisartan 80 mg; Drug: Amlodipine 10; Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
Active Comparator: Amlodipine 10; Amlodipine 5 for two weeks, then forced titration to Amlodipine 10	Drug: Amlodipine 10; Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8	Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.	Baseline, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6	Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.	Baseline, week 6
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4	Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.	Baseline, week 4
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2	Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.	Baseline, week 2
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1	Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.	Baseline, week 1
Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks	Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg	Baseline, week 8
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks	Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg	Baseline, week 6
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks	Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg	Baseline, week 4
BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks	Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg	Baseline, week 2
BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week	Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg	Baseline, week 1
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks	Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg	Baseline, week 8
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks	Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg	Baseline, week 6
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks	Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg	Baseline, week 4
BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks	Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg	Baseline, week 2
BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week	Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg	Baseline, week 1
Systolic Blood Pressure (SBP) Control 140 at Eight Weeks	Mean seated SBP < 140 mmHg	Baseline, week 8
SBP Control 140 at Six Weeks	Mean seated SBP < 140 mmHg	Baseline, week 6
SBP Control 140 at Four Weeks	Mean seated SBP < 140 mmHg	Baseline, week 4
SBP Control 140 at Two Weeks	Mean seated SBP < 140 mmHg	Baseline, week 2
SBP Control 140 at One Week	Mean seated SBP < 140 mmHg	Baseline, week 1
SBP Control 130 at Eight Weeks	Mean seated SBP < 130 mmHg	Baseline, week 8
SBP Control 130 at Six Weeks	Mean seated SBP < 130 mmHg	Baseline, week 6
SBP Control 130 at Four Weeks	Mean seated SBP < 130 mmHg	Baseline, week 4
SBP Control 130 at Two Weeks	Mean seated SBP < 130 mmHg	Baseline, week 2
SBP Control 130 at One Week	Mean seated SBP < 130 mmHg	Baseline, week 1
SBP Response 140 at Eight Weeks	SBP < 140 mmHg or a reduction >=10 mmHg	Baseline, week 8
SBP Response 140 at Six Weeks	SBP <140 mmHg or a reduction >=10 mmHg	Baseline, week 6
SBP Response 140 at Four Weeks	SBP <140 mmHg or a reduction >=10 mmHg	Baseline, week 4
SBP Response 140 at Two Weeks	SBP <140 mmHg or a reduction >=10 mmHg	Baseline, week 2
SBP Response 140 at One Week	SBP <140 mmHg or a reduction >=10 mmHg	Baseline, week 1
SBP Response 130 at Eight Weeks	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 8
SBP Response 130 at Six Weeks	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 6
SBP Response 130 at Four Weeks	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 4
SBP Response 130 at Two Weeks	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 2
SBP Response 130 at One Week	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 1
DBP Response at Eight Weeks	Mean seated DBP<80 mmHg or a reduction of <=10 mmHg	Week 8
DBP Response at Six Weeks	Mean seated DBP<80 mmHg or a reduction of <=10 mmHg	week 6
DBP Response at Week Four	Mean seated DBP <80 mmHg or a reduction of >=10 mmHg	Week 4
DBP Response at Week Two	Mean seated DBP <80 mmHg or a reduction of >=10 mmHg	Week 2
DBP Response at Week One	Mean seated DBP <80 mmHg or a reduction of >=10 mmHg	Week 1
Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)	Change from baseline in UACR (measured in spot urine) after eight weeks of treatment	8 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: April 7, 2009
• First Posted (Estimate): April 8, 2009

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Telmisartan
• Other Study ID Numbers: 1235.21; 2008-000874-19 (EudraCT Number: EudraCT)