amlodipine besylate/telmisartan / Generic mfg. - LARVOL DELTA

Impact of Baseline Body Mass Index on Effectiveness and Safety of Telmisartan-Amlodipine Fixed-Dose Combination in Indian Patients with Hypertension: Subgroup analysis of TACT India Real-World Study (ECO 2025) - No abstract available

Clinical • Real-world • Real-world evidence • Cardiovascular • Hypertension

Dyskalemia Prior to and After Initiation of a Fixed Dose Combination of Telmisartan and Amlodipine in Adults with Hypertension in Bangladesh. (PubMed, Glob Heart) - "1% self-reported mild symptoms (e.g., leg swelling), and there was one death of undetermined cause. Given low prevalence and incidence of hyperkalemia and evident reduction in BP, our study suggests initiating FDC with telmisartan and amlodipine may be a practical and safe option for newly diagnosed hypertension, especially in resource-constrained settings where blood tests cannot be easily obtained."

Journal • Cardiovascular • Hypertension

The Impact of Volume of Dissolution Medium for Biopredictive Dissolution/Permeation Studies of Enabling Formulations: A Comparison of Two Brands of Telmisartan / Amlodipine Tablets. (PubMed, J Pharm Sci) - "Dissolution/permeation studies of two commercial bilayer tablets (Twynsta® and Arrow) containing the active pharmaceutical ingredients telmisartan (40 mg) and amlodipine (10 mg) were evaluated using the MacroFlux tool with various biomimetic media mimicking fasted and fed states as well as biological variability ("biorelevant"). Amlodipine showed complete dissolution under any conditions, which correlates with its known complete absorption in vivo. In conclusion, volumes of dissolution media (and their compositions) are key parameters and play a significant role for designing relevant biomimetic experiments used to predict the bioavailability of supersaturating systems."

Journal • Gastrointestinal Disorder

Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension (clinicaltrials.gov) - P4 | N=250 | Recruiting | Sponsor: Yuhan Corporation | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Feb 2025 ➔ Jun 2025

Enrollment open • Head-to-Head • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Cardiovascular • Hypertension

Effectiveness and Safety of the Telmisartan and Amlodipine Fixed-dose Combination in Managing Hypertension among Indian Patients (TACT India Study): Rationale and Study Design. (PubMed, J Assoc Physicians India) - "The primary endpoint is to measure the change in systolic blood pressure (SBP) from baseline to week 8, while secondary endpoints include determining the percentage of patients who reach their blood pressure targets., description of demographic characteristics of the Indian hypertensive population, and reporting of safety outcomes. The TACT India study will provide longitudinal, real-world data on the effectiveness and safety of telmisartan and amlodipine FDC among a large cohort of the Indian population with hypertension."

Journal • Observational data • Cardiovascular • Hypertension

Pharmacokinetic Interactions Between the Fixed-Dose Combination of Ezetimibe/Rosuvastatin 10/20 Mg and the Fixed-Dose Combination of Telmisartan/Amlodipine 80/5 Mg in Healthy Subjects. (PubMed, Drug Des Devel Ther) - "The development of a fixed-dose combination (FDC) containing ezetimibe, rosuvastatin, telmisartan, and amlodipine aims to enhance patient adherence and persistence, but the potential interactions among the four medications have not been studied. Both combination therapy and monotherapy were well tolerated by the subjects. The coadministration of ezetimibe/rosuvastatin 10/20 mg and ezetimibe/rosuvastatin 10/20 mg was well tolerated in healthy subjects, and the PK interaction between those two FDCs was not clinically significant."

Journal • PK/PD data • Cardiovascular • Dyslipidemia • Hypertension

Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension (clinicaltrials.gov) - P4 | N=250 | Not yet recruiting | Sponsor: Yuhan Corporation

Head-to-Head • New P4 trial • Acute Myelogenous Leukemia • Cardiovascular • Hypertension

Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Boehringer Ingelheim | N=3275 ➔ 0 | Not yet recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Real-world evidence • Trial withdrawal • Cardiovascular • Hypertension

Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study. (PubMed, Clin Hypertens) - P4 | "Telmisartan40/S-Amlodipine2.5 was tolerable and more effective than Telmisartan80 in lowering 24-h mean ambulatory BP in patients with essential hypertension not responding adequately to Telmisartan40. Our findings support the fact that the combination of S-amlodipine with telmisartan is more appropriate than increasing the dose of telmisartan monotherapy."

Journal • Monotherapy • Chronic Kidney Disease • Diabetes • Hypertension • Metabolic Disorders • Nephrology • Renal Disease

QbD Consideration for Developing a Double-Layered Tablet into a Single-Layered Tablet with Telmisartan and Amlodipine. (PubMed, Pharmaceutics) - "The aim of this study was to develop a single-layered version of commercially available Twynstar (Telmisartan + Amlodipine) double-layered tablets to improve the dosing convenience. The selected quality-by-design (QbD) approach single-layered tablet formulated using design space were found to be bioequivalent to the Twynstar double-layered tablets. Hence, the development of single-layered tablets with two API using the QbD approach could improve the medication compliance of patients and could be used as a platform to overcome time-consuming and excessive costs and the technical and commercial limitations related to various multi-layered tablets."

Journal

Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice (clinicaltrials.gov) - P=N/A; N=3275; Not yet recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Jan 2022 ➔ Jul 2022; Trial primary completion date: Jan 2022 ➔ Jul 2022

Clinical • Combination therapy • Real-world evidence • Trial completion date • Trial primary completion date • Hypertension

Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice (clinicaltrials.gov) - P=N/A; N=3275; Not yet recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Jul 2021 ➔ Jan 2022; Trial primary completion date: Jul 2021 ➔ Jan 2022

Trial completion date • Trial primary completion date • Hypertension

Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine (clinicaltrials.gov) - P3; N=131; Completed; Sponsor: Addpharma Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Dyslipidemia • Hypertension • Metabolic Disorders

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Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice (clinicaltrials.gov) - P=N/A; N=3275; Not yet recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Dec 2020 ➔ Jul 2021; Trial primary completion date: Dec 2020 ➔ Jul 2021

Clinical • Combination therapy • Real-World Evidence • Trial completion date • Trial primary completion date • Hypertension

Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Hanlim Pharm. Co., Ltd.

Clinical • New P1 trial • Hypertension

Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine (clinicaltrials.gov) - P3; N=131; Active, not recruiting; Sponsor: Addpharma Inc.; Not yet recruiting ➔ Active, not recruiting; Trial completion date: May 2020 ➔ Jan 2021; Trial primary completion date: May 2020 ➔ Jan 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Dyslipidemia • Hypertension • Metabolic Disorders

Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice (clinicaltrials.gov) - P=N/A; N=3275; Not yet recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Jun 2020 ➔ Dec 2020; Trial primary completion date: Jun 2020 ➔ Dec 2020

Clinical • Combination therapy • Real-World Evidence • Trial completion date • Trial primary completion date • Hypertension

Pharmacokinetic interactions between telmisartan/amlodipine and rosuvastatin after multiple oral administrations in healthy Korean male subjects. (PubMed, Drug Des Devel Ther) - "The objective of this study was to evaluate the pharmacokinetic interaction between telmisartan/amlodipine fixed dose combination and rosuvastatin in healthy Korean male volunteers. The increase in systemic exposure to rosuvastatin caused by telmisartan/amlodipine co-administration would not be clinically significant in practice. Nevertheless, an appropriately designed two-sequence crossover study is needed to confirm the results of this study."

Clinical • Journal • PK/PD data

Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice (clinicaltrials.gov) - P=N/A; N=3275; Not yet recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Jan 2020 ➔ Jun 2020; Trial primary completion date: Jan 2020 ➔ Jun 2020

Clinical • Combination therapy • Real-World Evidence • Trial completion date • Trial primary completion date

Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/Amlodipine (clinicaltrials.gov) - P3; N=138; Not yet recruiting; Sponsor: Addpharma Inc.

Clinical • New P3 trial

Comparison of the Medication Adherence of Patients Treated With Telmisartan/Hydrochlorothiazide or Telmisartan/Amlodipine Fixed Dose Combination (FDC) Versus Double-pill Combination Therapy in Real-world Japanese Therapeutic Practice (clinicaltrials.gov) - P=N/A; N=3275; Not yet recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Jul 2019 ➔ Jan 2020; Trial primary completion date: Jul 2019 ➔ Jan 2020

Clinical • Combination therapy • Real-World Evidence • Trial completion date • Trial primary completion date