An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects

Start Date21 Dec 2018

Sponsor / Collaborator

Hanmi Pharmaceutical Co., Ltd.

NCT04081844 / CompletedPhase 1

An Open-label, Multiple Dose, Fixed-sequence, 3-period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions Between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects

Start Date03 May 2018

Sponsor / Collaborator

Hanmi Pharmaceutical Co., Ltd.

NCT02243319 / CompletedPhase 1

A Randomized, Open Label, Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904 in Healthy Male Subjects

The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Start Date01 Sep 2014

Sponsor / Collaborator

Hanmi Pharmaceutical Co., Ltd.

100 Clinical Results associated with Amlodipine Camsylate

100 Translational Medicine associated with Amlodipine Camsylate

100 Patents (Medical) associated with Amlodipine Camsylate

Literatures (Medical) associated with Amlodipine Camsylate

01 Nov 2018·HypertensionQ1 · MEDICINE

Aging Alters the Relative Contributions of the Sympathetic and Parasympathetic Nervous System to Blood Pressure Control in Women

Q1 · MEDICINE

Article

Author: Limberg, Jacqueline K. ; Joyner, Michael J. ; Curry, Timothy B. ; Nicholson, Wayne T. ; Baker, Sarah E. ; Dillon, Gabrielle A.

Autonomic support of blood pressure increases with age in humans. Large differences exist in the dose of trimethaphan (TMP) required for ganglionic blockade in young and older women. We asked whether differences in the dose of TMP required to achieve ganglionic blockade are because of differences in the relative contributions of the sympathetic and parasympathetic nervous system in control of blood pressure with age. Muscle sympathetic nerve activity (microneurography, peroneal nerve), heart rate (HR), and blood pressure were recorded before and during incremental doses of TMP camsylate until ganglionic blockade was achieved (absence of muscle sympathetic nerve activity and <5-bpm increase in HR during a valsalva maneuver; final TMP dose, 1–7 mg/min). HR variability was analyzed from the ECG waveform (WinCPRS). The dose of TMP required to achieve ganglionic blockade is positively related to basal HR variability, where women with high HR variability require a higher dose of TMP to achieve ganglionic blockade. In contrast, baseline muscle sympathetic nerve activity is inversely related with the dose of TMP required to achieve ganglionic blockade, such that women with high basal muscle sympathetic nerve activity required a lower dose of TMP. As such, the change in HR with ganglionic blockade was positively related, and the change in mean arterial pressure was inversely related, with the dose of TMP required to achieve ganglionic blockade. These data suggest loss of parasympathetic tone and increased sympathetic tone with aging contribute to the increase in blood pressure with age in women and dictate the dose of TMP that is necessary to achieve ganglionic blockade.

01 Dec 2017·Clinical Therapeutics

A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and the Tolerability of a Triple Combination of Amlodipine/Losartan/Rosuvastatin in Patients With Comorbid Essential Hypertension and Hyperlipidemia

Article

Author: Choi, Kee-Joon ; Yoo, Byung-Su ; Park, Seung Woo ; Rhee, Moo-Yong ; Shim, Jaemin ; Kim, Sang Min ; Jung, Hae Ok ; Oh, Ju Hyeon ; Choi, Joon Hyouk ; Choi, Si-Wan ; Hong, Taek-Jong ; Choi, Ji-Yong ; Kim, Woo-Shik ; Park, Dae-Gyun ; Lee, Hae-Young ; Cha, Dong-Hun ; Park, Tae Ho ; Lee, Kwang Je ; Song, Pil-Sang ; Rha, Seung-Woon ; Ryu, Dong-Ryeol ; Kim, Kye Hun ; Kim, Seok-Yeon

PURPOSEThe objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia.METHODSA randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertension and a sitting diastolic blood pressure (SiDBP) of >90 mm Hg and LDL-C levels <250mg/dL were screened. After a 4-week run-in period with therapeutic lifestyle changes and losartan potassium 100mg once daily, patients who met both blood pressure criteria (80 mm Hg ≤ SiDBP < 110 mm Hg) and the LDL-C level criteria (defined in the National Cholesterol Education Program Adult Treatment Panel III cardiovascular risk categories) were randomized to 1 of 3 groups and treated once daily for 8 weeks: losartan potassium 100mg + rosuvastatin 20mg treatment (L/R 100/20) group, amlodipine camsylate 5mg + losartan potassium 100mg treatment (A/L 5/100) group, and amlodipine 5mg+ losartan potassium 100mg + rosuvastatin 20mg (A/L/R 5/100/20) group. The primary efficacy variables were the percent change in LDL-C in the A/L/R 5/100/20 and A/L 5/100 groups and the mean change of SiDBP in the A/L/R 5/100/20 and L/R 100/20 groups after 8 weeks of treatment, relative to baseline values.FINDINGSA total of 146 patients were enrolled and the demographic characteristics were similar among the 3 treatment groups. After 8 weeks of treatment, the mean (SD) percent change in LDL-C was significantly greater in the A/L/R group than in the A/L group (-48.40% [2.77%] vs -6.70% [3.00%]; P < 0.0001). Moreover, the mean change in SiDBP was significantly greater in the A/L/R group than in the L/R group (-9.75 [0.92] mm Hg vs -1.73 [1.03] mm Hg; P < 0.0001). SiDBP and LDL-C reductions in the A/L/R group were comparable to reductions in the A/L and L/R groups, respectively. Ten adverse events were reported in 7 patients (4.83%), and 1 patient from the A/L group (0.69%) experienced 2 adverse drug reactions (tachycardia and face edema), which were mild and resolved without specific treatment. There were no clinically significant tolerability issues during the treatment period.IMPLICATIONSTriple combination therapy with amlodipine/losartan/rosuvastatin can be an effective therapeutic strategy in patients with hypertension combined with dyslipidemia. These findings will form the foundation of the future development of a single-pill triple combination. ClinicalTrials.gov identifier: NCT02899455.

01 Oct 2014·Clinical TherapeuticsQ4 · MEDICINE

Efficacy and Tolerability of Amlodipine Camsylate/Losartan 5/100-mg Versus Losartan/Hydrochlorothiazide 100/12.5-mg Fixed-Dose Combination in Hypertensive Patients Nonresponsive to Losartan 100-mg Monotherapy

Q4 · MEDICINE

Article

Author: Ahn, Taehoon ; Hyon, Min Su ; Kim, Won Ho ; Han, Kyoo Rok ; Lee, Seoung Uk ; Kim, Young Kwon ; Bae, Jang-Ho ; Suh, Soon Yong ; Lim, Do-Sun ; Park, Hoon Ki

PURPOSEThe aim of this study was to determine whether the efficacy and tolerability of amlodipine camsylate/losartan 5/100 mg/d (AML/LOS) are noninferior to those of losartan/hydrochlorothiazide 100/12.5 mg/d (LOS/HCTZ) fixed-dose combination in hypertensive patients unresponsive to losartan 100-mg/d monotherapy.METHODSMale and female patients aged ≥ 18 years with hypertension despite 4-week, stable treatment with losartan 100-mg/d monotherapy were eligible for inclusion in this multicenter, randomized, double-blind study. Patients were randomly assigned to receive AML/LOS or LOS/HCTZ once daily for 8 weeks. The primary end point was the change from baseline to week 8 in sitting diastolic blood pressure (ΔsiDBP), and the secondary end points were the changes from baseline to 4 weeks in siDBP and sitting systolic BP (ΔsiSBP) and changes from baseline to 4 and 8 weeks in BP response rate. Tolerability was evaluated by physical examination, including vital sign measurement; laboratory analysis; and ECG.FINDINGSOf 275 patients screened at 9 cardiovascular centers, 199 were enrolled (AML/LOS, n = 101; LOS/HCTZ, n = 98), and 183 completed the study. The demographic characteristics were similar between the 2 groups (mean age, 51.56 [9.97] years; men, 70.53%). At 8 weeks, the mean ΔsiDBP values were -11.54 (7.89) and -9.05 (6.57) mm Hg in the AML/LOS and LOS/HCTZ groups, respectively (both, P < 0.0001 vs baseline). The mean difference between the 2 groups was -2.57 mm Hg, a nonsignificant difference, meaning that AML/LOS was noninferior to LOS/HCTZ with regard to the primary end point. At 8 weeks, the mean uric acid level was changed significantly from baseline in the LOS/HCTZ group (+0.41 [0.80] mg/dL; P < 0.0001) but not in the AML/LOS group (-0.12 [0.82] mg/dL), representing a significant intergroup difference (P < 0.0001). Nineteen patients each in the AML/LOS (18.81%) and LOS/HCTZ (20.00%) groups experienced ≥ 1 adverse event, with 4 (3.96%) and 3 (3.16%) patients, respectively, experiencing 1 or more events considered by the investigators to have been treatment related.IMPLICATIONSThe efficacy and tolerability of AML/LOS 5/100 mg/d was found to have been noninferior to those of LOS/HCTZ 100/12.5 mg/d in these hypertensive patients nonresponsive to losartan 100-mg/d monotherapy.

100 Deals associated with Amlodipine Camsylate

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Hypertension	KR	Hanmi Pharmaceutical Co., Ltd.	08 Jun 2004

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