Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Al… (NCT00853957) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension
United States443 participantsStarted 2009-02
Plain-language summary
The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Men or women of African American background; self identified
* Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and \< 200 mmHg at Visit 5 (randomization
Exclusion Criteria:
* Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
* Patients on 4 or more antihypertensive medications.
* Patients with uncontrolled hypertension (MSSBP \>180 mmHg) taking more than 1 antihypertensive medication at Visit 1
* Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Evidence of a secondary form of hypertension, including but not limited to any of the following:
* coarctation of the aorta
* hyperaldosteronism
* unilateral or bilateral renal artery stenosis
* Cushing's disease
* polycystic kidney disease
* pheochromocytoma
* Known Keith-Wagener grade III or IV hypertensive retinopathy.
* History of angioedema due to usage of an ARB or ACE inhibitor.
* History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), co…
What they're measuring
1
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)