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Clinical Trial Details

Trial ID: L2514
Source ID: NCT00877929
Associated Drug: Telmisartan 80
Title: Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00877929/results
Conditions: Hypertension
Interventions: DRUG: Telmisartan 80|DRUG: Amlodipine 10|DRUG: Amlodipine 10
Outcome Measures: 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 | 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|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
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 706
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2009-02
Completion Date:
Results First Posted: 2011-06-07
Last Update Posted: 2014-03-12
Locations: 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|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
URL: https://clinicaltrials.gov/show/NCT00877929