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

NCT00877929 | Completed Phase 3 Results

• 2 other identifiers: 1235.212008-000874-19
• Study Type: interventional
• Target: 706
• Locations: 9 countries
• Sites: 65

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (40)

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

  Baseline, week 6

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

  Baseline, week 4

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

  Baseline, week 2

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

  Baseline, week 1

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

  Baseline, week 8

Study Arms (2)

Telmisartan 80 / Amlodipine 10

EXPERIMENTAL

Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination

Drug: Telmisartan 80; Drug: Amlodipine 10

Amlodipine 10

ACTIVE COMPARATOR

Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Drug: Amlodipine 10

Interventions

Telmisartan 80 DRUG

Telmisartan 80 mg

Telmisartan 80 / Amlodipine 10

Amlodipine 10 DRUG

Amlodipine 5 for two weeks, then forced titration to Amlodipine 10

Telmisartan 80 / Amlodipine 10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pre-menopausal women (last menstruation \<=1 year prior to start of run-in period) who:
• are not surgically sterile; and/or
• are nursing or pregnant, or
• 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
• Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 a.m.
• Known or suspected secondary hypertension (e.g., renal artery stenosis, phaeochromocytoma)
• 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
• Patients with Type 1 diabetes mellitus
• 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
• Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (65)

1235.21.901 Boehringer Ingelheim Investigational Site

Long Beach, California, United States

Location

1235.21.907 Boehringer Ingelheim Investigational Site

Tustin, California, United States

Location

1235.21.913 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

1235.21.910 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Location

1235.21.903 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

1235.21.905 Boehringer Ingelheim Investigational Site

Tucker, Georgia, United States

Location

1235.21.916 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

Location

1235.21.915 Boehringer Ingelheim Investigational Site

Hickory, North Carolina, United States

Location

1235.21.906 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1235.21.902 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1235.21.904 Boehringer Ingelheim Investigational Site

Penndel, Pennsylvania, United States

Location

1235.21.908 Boehringer Ingelheim Investigational Site

Carrollton, Texas, United States

Location

1235.21.909 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1235.21.912 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1235.21.911 Boehringer Ingelheim Investigational Site

Ettrick, Virginia, United States

Location

1235.21.102 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1235.21.103 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1235.21.107 Boehringer Ingelheim Investigational Site

Ramos Mejía, Argentina

Location

1235.21.101 Boehringer Ingelheim Investigational Site

Santa Fe, Argentina

Location

1235.21.105 Boehringer Ingelheim Investigational Site

Zárate, Argentina

Location

1235.21.302 Boehringer Ingelheim Investigational Site

Acapulco, Mexico

Location

1235.21.304 Boehringer Ingelheim Investigational Site

Aguascalientes, Mexico

Location

1235.21.301 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1235.21.303 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1235.21.305 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1235.21.306 Boehringer Ingelheim Investigational Site

Guadalajara, Mexico

Location

1235.21.408 Boehringer Ingelheim Investigational Site

Beek en Donk, Netherlands

Location

1235.21.401 Boehringer Ingelheim Investigational Site

Hoogwoud, Netherlands

Location

1235.21.405 Boehringer Ingelheim Investigational Site

Musselkanaal, Netherlands

Location

1235.21.404 Boehringer Ingelheim Investigational Site

Nijverdal, Netherlands

Location

1235.21.403 Boehringer Ingelheim Investigational Site

Oude Pekela, Netherlands

Location

1235.21.409 Boehringer Ingelheim Investigational Site

Roelofarensveen, Netherlands

Location

1235.21.406 Boehringer Ingelheim Investigational Site

The Hague, Netherlands

Location

1235.21.407 Boehringer Ingelheim Investigational Site

Voerendaal, Netherlands

Location

1235.21.402 Boehringer Ingelheim Investigational Site

Wildervank, Netherlands

Location

1235.21.501 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1235.21.502 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1235.21.503 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1235.21.504 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

Location

1235.21.507 Boehringer Ingelheim Investigational Site

Dunajská Streda, Slovakia

Location

1235.21.509 Boehringer Ingelheim Investigational Site

Martin, Slovakia

Location

1235.21.505 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1235.21.506 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1235.21.508 Boehringer Ingelheim Investigational Site

Rimavská Sobota, Slovakia

Location

1235.21.27005 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.21.27007 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1235.21.27004 Boehringer Ingelheim Investigational Site

Durban, South Africa

Location

1235.21.27006 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1235.21.27002 Boehringer Ingelheim Investigational Site

Krugersdorp, South Africa

Location

1235.21.27001 Boehringer Ingelheim Investigational Site

Lenasia, South Africa

Location

1235.21.27003 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

1235.21.202 Boehringer Ingelheim Investigational Site

Incheon, South Korea

Location

1235.21.201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.21.203 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.21.204 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.21.205 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1235.21.702 Boehringer Ingelheim Investigational Site

Castellon, Spain

Location

1235.21.705 Boehringer Ingelheim Investigational Site

Centelles, Spain

Location

1235.21.703 Boehringer Ingelheim Investigational Site

Sant Adrià Del Besós, Spain

Location

1235.21.704 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet (Barcelona), Spain

Location

1235.21.706 Boehringer Ingelheim Investigational Site

Santa Coloma de Gramanet, Spain

Location

1235.21.801 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1235.21.803 Boehringer Ingelheim Investigational Site

Helsingborg, Sweden

Location

1235.21.804 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

1235.21.802 Boehringer Ingelheim Investigational Site

Västerås, Sweden

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: April 8, 2009
• Study Start: February 1, 2009
• Primary Completion: May 1, 2010
• Last Updated: March 12, 2014
• Results First Posted: June 7, 2011

Record last verified: 2014-02

Locations

AR (5); ME (6); ZA (7); ES (5); SE (4); NL (9); US (15); KR (5); SL (9)