Last updated: 11/04/2018 08:34:51
Lacidipine In Mild To Moderate Essential Hypertension Patients With Type 2 Diabetes In Korea
GSK study ID
LAC103842
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open label, multi-centre, single arm phase IV study to evaluate the antihypertensive effect of Lacidipine in mild to moderate essential hypertension patients with Type 2 diabetes in Korea
Trial description: This study was designed to evaluate the anti-hypertensive efficacy of lacidipine in hypertensives with Type 2 diabetes and effectiveness on endothelial cell function in Korean population.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Change from Baseline in the mean systolic blood pressure (SBP) at Week 12
Timeframe: Baseline (Week 0) and Week 12
Secondary outcomes:
Change from Baseline in the mean diastolic blood pressure (DBP) at Week 12
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline in the flow-mediated vasodilation (FMD) at Week 12
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline in level of high sensitivity C-reactive protein (hsCRP) at Week 12
Timeframe: Baseline (Week 0) and Week 12
Change from Baseline in level of macrophage chemoattractant protein-1 (MCP-1), matrix metalloproteases-9 (MMP-9) and plasminogen activator inhibitor-1 (PAI-1) at Week 12
Timeframe: Baseline (Week 0) and Week 12
Interventions:
Drug: Lacidipine
Enrollment:
290
Observational study model:
Not applicable
Primary completion date:
2005-30-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Diabetes Mellitus, Type 2
Product
lacidipine
Collaborators
Not applicable
Study date(s)
November 2004 to August 2005
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
35 - 75 years
Accepts healthy volunteers
No
- Newly diagnosed as essential hypertension or not treated in the past 2 weeks(If the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week –2) assessments)
- Mean seated SBP at screen visit = 130mmHg (as measured by a mercury sphygmomanometer)
- Mean seated SBP of > 180 mmHg
- Known or suspected secondary hypertension
Inclusion and exclusion criteria
Inclusion criteria:
- Newly diagnosed as essential hypertension or not treated in the past 2 weeks(If the subject took medication in the past 2 weeks, a wash-out period of at least 2 weeks will be completed prior to performing screening (week –2) assessments)
- Mean seated SBP at screen visit = 130mmHg (as measured by a mercury sphygmomanometer)
- Type 2 diabetes (American Diabetes Association criteria 2004) and HbA1C <11%
- Agree to practice acceptable contraceptive measures during the study, and for 30 days after the last dose of study medication is taken if the subject a female of child-bearing potential
- Provide written informed consent
Exclusion criteria:
- Mean seated SBP of > 180 mmHg
- Known or suspected secondary hypertension
- Anemia defined by haemoglobin concentration < 10.0 g/dL
- Hemoglobinopathy or peripheral vascular disease
- Clinically significant renal or hepatic disease (i.e., subjects with serum creatinine = 2.0 mg/dL; Alanine aminotransferase, Aspartate aminotransferase, total bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal reference range)
- Unstable or severe angina, coronary insufficiency, or any congestive heart failure requiring pharmacologic treatment
- Chronic disease requiring intermittent or chronic treatment with oral, intravenous, or intra-articular corticosteroids (i.e. only use of topical, inhaled or nasal corticosteroids is permissible)
- Female who is lactating, pregnant, or planning to become pregnant
- clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory tests, or electrocardiogram etc.)
- Acute or chronic metabolic acidosis or a history of diabetic ketoacidosis
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2005-30-08
Actual study completion date
2005-30-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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