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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00877929
First received: February 6, 2009
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Telmisartan 80
Drug: Amlodipine 10
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8 [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.


Secondary Outcome Measures:
  • Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6 [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

  • Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

  • Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2 [ Time Frame: Baseline, week 2 ] [ Designated as safety issue: No ]
    Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

  • Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1 [ Time Frame: Baseline, week 1 ] [ Designated as safety issue: No ]
    Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.

  • Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

  • BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

  • BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

  • BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks [ Time Frame: Baseline, week 2 ] [ Designated as safety issue: No ]
    Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

  • BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week [ Time Frame: Baseline, week 1 ] [ Designated as safety issue: No ]
    Mean seated SBP<140 mmHg and mean seated DBP<90 mmHg

  • BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

  • BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

  • BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

  • BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks [ Time Frame: Baseline, week 2 ] [ Designated as safety issue: No ]
    Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

  • BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week [ Time Frame: Baseline, week 1 ] [ Designated as safety issue: No ]
    Mean seated SBP<130 mmHg and mean seated DBP<80 mmHg

  • Systolic Blood Pressure (SBP) Control 140 at Eight Weeks [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    Mean seated SBP < 140 mmHg

  • SBP Control 140 at Six Weeks [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    Mean seated SBP < 140 mmHg

  • SBP Control 140 at Four Weeks [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    Mean seated SBP < 140 mmHg

  • SBP Control 140 at Two Weeks [ Time Frame: Baseline, week 2 ] [ Designated as safety issue: No ]
    Mean seated SBP < 140 mmHg

  • SBP Control 140 at One Week [ Time Frame: Baseline, week 1 ] [ Designated as safety issue: No ]
    Mean seated SBP < 140 mmHg

  • SBP Control 130 at Eight Weeks [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    Mean seated SBP < 130 mmHg

  • SBP Control 130 at Six Weeks [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    Mean seated SBP < 130 mmHg

  • SBP Control 130 at Four Weeks [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    Mean seated SBP < 130 mmHg

  • SBP Control 130 at Two Weeks [ Time Frame: Baseline, week 2 ] [ Designated as safety issue: No ]
    Mean seated SBP < 130 mmHg

  • SBP Control 130 at One Week [ Time Frame: Baseline, week 1 ] [ Designated as safety issue: No ]
    Mean seated SBP < 130 mmHg

  • SBP Response 140 at Eight Weeks [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    SBP < 140 mmHg or a reduction >=10 mmHg

  • SBP Response 140 at Six Weeks [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    SBP <140 mmHg or a reduction >=10 mmHg

  • SBP Response 140 at Four Weeks [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    SBP <140 mmHg or a reduction >=10 mmHg

  • SBP Response 140 at Two Weeks [ Time Frame: Baseline, week 2 ] [ Designated as safety issue: No ]
    SBP <140 mmHg or a reduction >=10 mmHg

  • SBP Response 140 at One Week [ Time Frame: Baseline, week 1 ] [ Designated as safety issue: No ]
    SBP <140 mmHg or a reduction >=10 mmHg

  • SBP Response 130 at Eight Weeks [ Time Frame: Baseline, week 8 ] [ Designated as safety issue: No ]
    SBP <130 mmHg or a reduction >=10 mmHg

  • SBP Response 130 at Six Weeks [ Time Frame: Baseline, week 6 ] [ Designated as safety issue: No ]
    SBP <130 mmHg or a reduction >=10 mmHg

  • SBP Response 130 at Four Weeks [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    SBP <130 mmHg or a reduction >=10 mmHg

  • SBP Response 130 at Two Weeks [ Time Frame: Baseline, week 2 ] [ Designated as safety issue: No ]
    SBP <130 mmHg or a reduction >=10 mmHg

  • SBP Response 130 at One Week [ Time Frame: Baseline, week 1 ] [ Designated as safety issue: No ]
    SBP <130 mmHg or a reduction >=10 mmHg

  • DBP Response at Eight Weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Mean seated DBP<80 mmHg or a reduction of <=10 mmHg

  • DBP Response at Six Weeks [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    Mean seated DBP<80 mmHg or a reduction of <=10 mmHg

  • DBP Response at Week Four [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Mean seated DBP <80 mmHg or a reduction of >=10 mmHg

  • DBP Response at Week Two [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Mean seated DBP <80 mmHg or a reduction of >=10 mmHg

  • DBP Response at Week One [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    Mean seated DBP <80 mmHg or a reduction of >=10 mmHg

  • Change From Baseline in Urine Albumin:Creatinine Ratio (UACR) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in UACR (measured in spot urine) after eight weeks of treatment


Enrollment: 706
Study Start Date: February 2009
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877929

  Show 65 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00877929     History of Changes
Other Study ID Numbers: 1235.21, 2008-000874-19
Study First Received: February 6, 2009
Results First Received: May 13, 2011
Last Updated: February 10, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Netherlands: Central Committee Research Involving Human Subjects
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Spain: Agencia Española del medicamento y Productos Sanitarios (AEMPS) Subdirección General de Medicamentos de uso humano Parque empresarial las Mercedes, edificio 8 C/ Campezo, 1 28022 Madrid / SPAIN
Sweden: Medical Products Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hypertension
Cardiovascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Amlodipine
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014