Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension

NCT00772577 | Completed Phase 4 Results

• 1 other identifier: CSPP100AUS07
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Hypertension

Keywords

Hypertension, Obese, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, ramipril, stage 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)

  To assess the change in mean sitting systolic blood pressure (MSSBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

  Baseline to week 8

Secondary Outcomes (4)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)

  Baseline to week 8

• Percentage of Patients Achieving Blood Pressure Control During 8 Weeks

  8 weeks

• Percentage of Responders (MSSBP < 140 mmHg or ≥ 20 mmHg Decrease From Baseline in MSSBP)

  8 weeks

• Change From Baseline in Mean Sitting Pulse Pressure (MSPP)

  Baseline to week 8

Study Arms (2)

1

EXPERIMENTAL

Aliskiren Hydrochlorothiazide(HCTZ)

Drug: Aliskiren Hydrochlorothiazide

2

ACTIVE COMPARATOR

Ramipril

Drug: Ramipril

Interventions

Aliskiren Hydrochlorothiazide DRUG

Aliskiren HCTZ 150/12.5 mg: 1 week; Aliskiren HCTZ 300/25 mg: 7 weeks

1

Ramipril DRUG

Ramipril 5mg: 1 week; Ramipril 10 mg: 7 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (6)

Investigative Site

Beverly Hills, California, United States

Location

Investigative Site

Santa Ana, California, United States

Location

Investigative Site

Conyers, Georgia, United States

Location

Investigative Site

Lexington, Kentucky, United States

Location

Investigative Site

Columbia, South Carolina, United States

Location

Investigative Site

Houston, Texas, United States

Location

MeSH Terms

Conditions

Hypertension; Obesity

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 15, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 11, 2011
• Results First Posted: March 2, 2011

Record last verified: 2011-03

Locations

US (6)