Clinical trial NCT00772577: Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
Official title: An 8-Week Prospective, Multicenter, Randomized, Double-Blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to Evaluate the Efficacy and Safety of Aliskiren Hydrochlorothiazide (HCTZ) vs Ramipril in Obese patients (BMI ≥ 30) with Stage 2 Hypertension


Eligibility criteria: Inclusion Criteria:

* Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
* Male or female outpatients, 18 years of age and older.
* Patients with Stage 2 hypertension. Patients must have a MSSBP ≥ 160 mmHg and \< 200 mmHg at Study Visit 5 (randomization).
* Patients must have a BMI ≥ 30 kg/m2 but ≤ 45 kg/m2.

Exclusion Criteria:

* Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg) at any visit.
* Use of other investigational drugs within 30 days of enrollment, or 5 half-lives, which ever is longer.
* Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
* History of hypersensitivity to any of the study drugs or to drugs belonging to the same therapeutic class (ACE inhibitors or renin inhibitors) as the study drugs.
* History or evidence of a secondary form of hypertension.
* 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.
* Patients on 4 or more antihypertensive medications.
* Long QT syndrome or QTc \> 450 msec for males and \> 470 msec for females at screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)
timeFrame: Baseline to week 8
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
timeFrame: Baseline to week 8
measure: Percentage of Patients Achieving Blood Pressure Control During 8 Weeks
timeFrame: 8 weeks
measure: Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)
timeFrame: 8 weeks
measure: Change From Baseline in Mean Sitting Pulse Pressure (MSPP)
timeFrame: Baseline to week 8
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Investigative Site
state: California
city: Santa Ana
country: United States
facility: Investigative Site
state: California
city: Conyers
country: United States
facility: Investigative Site
state: Georgia
city: Lexington
country: United States
facility: Investigative Site
state: Kentucky
city: Columbia
country: United States
facility: Investigative Site
state: South Carolina
city: Houston
country: United States
facility: Investigative Site
state: Texas
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: