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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877929
• Other study ID #: 1235.21
• Secondary ID: 2008-000874-19
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2009
• Last updated: February 10, 2014
• Start date: February 2009

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia MedicaKorea, Republic of: Korea Food and Drug Administration (KFDA)Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)Netherlands: Central Committee Research Involving Human SubjectsSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: 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 / SPAINSweden: Medical Products AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 706
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Telmisartan 80
Telmisartan 80 mg
• Amlodipine 10
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
• Amlodipine 10
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Locations

Country	Name	City	State
Argentina	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
Korea, Republic of	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
Mexico	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
Netherlands	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
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	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
South Africa	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
Spain	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	1235.21.706 Boehringer Ingelheim Investigational Site	Santa Coloma de Gramanet
Spain	1235.21.704 Boehringer Ingelheim Investigational Site	Santa Coloma de Gramanet (Barcelona)
Sweden	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
United States	1235.21.908 Boehringer Ingelheim Investigational Site	Carrollton	Texas
United States	1235.21.909 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	1235.21.911 Boehringer Ingelheim Investigational Site	Ettrick	Virginia
United States	1235.21.913 Boehringer Ingelheim Investigational Site	Fort Lauderdale	Florida
United States	1235.21.915 Boehringer Ingelheim Investigational Site	Hickory	North Carolina
United States	1235.21.910 Boehringer Ingelheim Investigational Site	Hollywood	Florida
United States	1235.21.912 Boehringer Ingelheim Investigational Site	Killeen	Texas
United States	1235.21.901 Boehringer Ingelheim Investigational Site	Long Beach	California
United States	1235.21.902 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	1235.21.916 Boehringer Ingelheim Investigational Site	Olive Branch	Mississippi
United States	1235.21.903 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	1235.21.904 Boehringer Ingelheim Investigational Site	Penndel	Pennsylvania
United States	1235.21.905 Boehringer Ingelheim Investigational Site	Tucker	Georgia
United States	1235.21.907 Boehringer Ingelheim Investigational Site	Tustin	California
United States	1235.21.906 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Korea, Republic of,  Mexico,  Netherlands,  Slovakia,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Systolic Blood Pressure (SBP) Control 140 at Eight Weeks	Mean seated SBP < 140 mmHg	Baseline, week 8	No
Secondary	SBP Control 140 at Six Weeks	Mean seated SBP < 140 mmHg	Baseline, week 6	No
Secondary	SBP Control 140 at Four Weeks	Mean seated SBP < 140 mmHg	Baseline, week 4	No
Secondary	SBP Control 140 at Two Weeks	Mean seated SBP < 140 mmHg	Baseline, week 2	No
Secondary	SBP Control 140 at One Week	Mean seated SBP < 140 mmHg	Baseline, week 1	No
Secondary	SBP Control 130 at Eight Weeks	Mean seated SBP < 130 mmHg	Baseline, week 8	No
Secondary	SBP Control 130 at Six Weeks	Mean seated SBP < 130 mmHg	Baseline, week 6	No
Secondary	SBP Control 130 at Four Weeks	Mean seated SBP < 130 mmHg	Baseline, week 4	No
Secondary	SBP Control 130 at Two Weeks	Mean seated SBP < 130 mmHg	Baseline, week 2	No
Secondary	SBP Control 130 at One Week	Mean seated SBP < 130 mmHg	Baseline, week 1	No
Secondary	SBP Response 140 at Eight Weeks	SBP < 140 mmHg or a reduction >=10 mmHg	Baseline, week 8	No
Secondary	SBP Response 140 at Six Weeks	SBP <140 mmHg or a reduction >=10 mmHg	Baseline, week 6	No
Secondary	SBP Response 140 at Four Weeks	SBP <140 mmHg or a reduction >=10 mmHg	Baseline, week 4	No
Secondary	SBP Response 140 at Two Weeks	SBP <140 mmHg or a reduction >=10 mmHg	Baseline, week 2	No
Secondary	SBP Response 140 at One Week	SBP <140 mmHg or a reduction >=10 mmHg	Baseline, week 1	No
Secondary	SBP Response 130 at Eight Weeks	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 8	No
Secondary	SBP Response 130 at Six Weeks	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 6	No
Secondary	SBP Response 130 at Four Weeks	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 4	No
Secondary	SBP Response 130 at Two Weeks	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 2	No
Secondary	SBP Response 130 at One Week	SBP <130 mmHg or a reduction >=10 mmHg	Baseline, week 1	No
Secondary	DBP Response at Eight Weeks	Mean seated DBP<80 mmHg or a reduction of <=10 mmHg	Week 8	No
Secondary	DBP Response at Six Weeks	Mean seated DBP<80 mmHg or a reduction of <=10 mmHg	week 6	No
Secondary	DBP Response at Week Four	Mean seated DBP <80 mmHg or a reduction of >=10 mmHg	Week 4	No
Secondary	DBP Response at Week Two	Mean seated DBP <80 mmHg or a reduction of >=10 mmHg	Week 2	No
Secondary	DBP Response at Week One	Mean seated DBP <80 mmHg or a reduction of >=10 mmHg	Week 1	No
Secondary	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	No

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