Combination of OLMesartan and CCB or Low Dose Diuretics in High Risk Elderly Hypertensive Patients Study (COLM-Study)
Condition: Hypertension; Cardiovascular Disease; Diabetes
MeSH terms: Hypertension; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate which combination therapy is more effective in
      reducing the incidence of cardiovascular events in Japanese elderly high-risk hypertensive
      patients: AT1 subtype angiotensin II receptor antagonist/calcium channel blocker or AT1
      subtype angiotensin II receptor antagonist/low dose diuretic.
    

Detailed description: 
      Recently, antihypertensive combination therapies have been recommended by various guidelines
      because of their additive effects. Combination therapies of AT1 subtype angiotensin II
      receptor antagonist and calcium channel blocker or low dose diuretic have shown
      pharmacological benefit. However, reduction of cardiovascular events and safety profile of
      these combination therapies under same level of antihypertensive target have not been
      investigated yet.

      In this study, primary objective is to compare two combination therapies when
      antihypertensive target is 140/90mmHg in elderly hypertensive patients with high
      cardiovascular risk.

      Further study details as provided by COLM-Study data center

      Primary Outcomes: A composite of fatal and non-fatal cardiovascular events: Sudden death
      (death of endogenous origin within 24 hours after acute onset); Cerebrovascular events (new
      occurrence or recurrence of a cerebral infarction, cerebral hemorrhage, subarachnoid
      hemorrhage or transient ischemic attack); Coronary events (new occurrence or recurrence of a
      myocardial infarction, coronary revascularization[PCI or CABG], hospitalization for angina
      pectoris, hospitalization for heart failure); Renal dysfunction (doubling of serum creatinine
      and creatinine ≥2.0 mg/dl, end stage renal disease) Secondary Outcomes: All deaths; Death
      from cardiovascular events; Effects on glucose metabolism(fasting plasma glucose,
      postprandial glucose, new onset of diabetes mellitus); Incidence of primary outcomes events;
      New occurrence of atrial fibrillation; Safety; Proportion of the subjects who withdrew from
      the allocated treatment
    

Intervention name(s): olmesartan medoxomil / amlodipine or azelnidipine; olmesartan medoxomil / low dose thiazide type drug
Intervention type(s): Drug; Drug
Intervention description(s): AT1 subtype angiotensin II receptor antagonist / calcium channel blocker : 5-40mg of olmesartan medoxomil / 2.5-5mg of amlodipine or 8-16mg of azelnidipine; AT1 subtype angiotensin II receptor antagonist / low dose diuretic : 5-40mg of olmesartan medoxomil / low dose thiazide type drug
Intervention MeSH terms: Amlodipine; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Elderly; Hypertension; Cardiovascular Diseases; Angiotensin II Type 1 Receptor Blockers; Calcium Channel Blockers; Diuretics; Combination Drug Therapy; Diabetes