Evidence map›Paper›PMID 25231512›Full record

Trial reportJournal of human hypertension2015

Efficacy and safety of the dual L- and T-type calcium channel blocker, ACT-280778: a proof-of-concept study in patients with mild-to-moderate essential hypertension.

J Dingemanse, P Otasevic, K Shakeri-Nejad, E Klainman, B Putnikovic, H Kracker, M S Mueller, R Zimlichman

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of human hypertension, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 3 pooled it
–field-weighted citation impact, top 91% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 3 countries.

J DingemanseActelion Pharmaceuticals Ltd, Department of Clinical Pharmacology, Allschwil, Switzerland.
P OtasevicDedinje Cardiovascular Institute, University of Belgrade, Belgrade, Serbia.
K Shakeri-NejadActelion Pharmaceuticals Ltd, Department of Clinical Pharmacology, Allschwil, Switzerland.
E KlainmanGefen Cardiac Health Centre, Givatayim and Israeli Academic College, Ramat-Gan, Israel.
B PutnikovicClinical Hospital Center Zemun, University of Belgrade, Belgrade, Serbia.
H KrackerActelion Pharmaceuticals Ltd, Department of Biostatistics, Allschwil, Switzerland.
M S MuellerActelion Pharmaceuticals Ltd, Department of Clinical Pharmacology, Allschwil, Switzerland.
R ZimlichmanWolfson Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Actelion (Switzerland) · CHUniversity of Belgrade · RSWolfson Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ACT-280778 is an oral, non-dihydropyridine, dual L-/T-type calcium channel blocker. This phase 2a, double-blind, randomized, placebo- and active-controlled study investigated the efficacy and safety of 10 mg ACT-280778. Patients with mild-to-moderate essential hypertension received once-daily placebo (n=53), ACT-280778 10 mg (n=52) or amlodipine 10 mg (n=54) for 4 weeks. The primary end point was the change from baseline to week 4 in placebo-adjusted mean trough sitting diastolic blood pressure (SiDBP) with ACT-280778. Tolerability was assessed by recording treatment-emergent adverse events (TEAEs). Baseline clinical characteristics were similar across groups. No significant difference was observed at week 4 in mean trough SiDBP between placebo (-9.9 (95% confidence limit (CL) -12.7, -7.0) mm Hg) and ACT-280778 (-9.5 (-12.4, -6.5) mm Hg; P=0.86); amlodipine reduced mean trough SiDBP by -16.8 (-19.0, -14.5) mm Hg, confirming assay validity. Change in mean PR interval at week 4 (pre-dose) differed between placebo (-1.0 (95% CL -4.4, 2.3) ms) and ACT-280778 (6.5 (3.5, 9.6) ms); amlodipine did not increase PR interval (1.1 (-1.6, 3.9) ms).Treatment-emergent adverse events (TEAE) frequency was 32.1% (placebo), 32.7% (ACT-280778) and 33.3% (amlodipine). The most common TEAEs were headache, peripheral edema, hypertension and second-degree atrioventricular block. ACT-280778 (10 mg) did not lower blood pressure in mild-to-moderate hypertension.

Indexed as

Administration, OralAdultAgedAmlodipineAntihypertensive AgentsBenzimidazolesBlood PressureBridged Bicyclo CompoundsCalcium Channel BlockersCalcium Channels, L-TypeCalcium Channels, T-TypeDouble-Blind MethodDrug Administration ScheduleFemaleHumansHypertensionAmlodipineAntihypertensive AgentsBenzimidazolesBridged Bicyclo CompoundsCalcium Channel BlockersCalcium Channels, L-TypeCalcium Channels, T-Typeisobutyric acid 2-(2-((3-(4,7-dimethoxy-1H-benzoimidazol-2-yl)propyl)methylamino)ethyl)-5-phenylbicyclo(2.2.2)oct-5-en-2-yl ester

Identifiers

PMID25231512
OpenAlexW1982378515

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.