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Completed

NCT Number: NCT00772577

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Site, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aliskiren Hydrochlorothiazide

Drug

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

Ramipril

Drug

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

Primary outcomes

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

    Time frame: Baseline to week 8

    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).

Secondary outcomes

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

    Time frame: Baseline to week 8

    To evaluate the difference in mean sitting diastolic blood pressure (MSDBP) after 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg).

  2. Percentage of Patients Achieving Blood Pressure Control During 8 Weeks

    Time frame: 8 weeks

    The percentage of patients achieving the Blood Pressure control (defined as patients achieving a MSSBP < 140 mm Hg and MSDBP < 90 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving blood pressure control before or at the 8 week visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.

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

    Time frame: 8 weeks

    To compare the percentage of responders (as defined by patients with MSSBP < 140 mm Hg or a decrease from baseline ≥ 20 mm Hg) during 8 weeks of treatment with aliskiren HCTZ (150/12.5 mg, 300/25 mg) versus ramipril (5 mg, 10 mg). Data presented are cumulative. Cumulative refers to achieving the response before or at the 8 week visit. If response occurred more than once, only the first occurrence was counted.

  4. Change From Baseline in Mean Sitting Pulse Pressure (MSPP)

    Time frame: Baseline to week 8

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Acronym: ATTAIN

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2008
Registry last updated
Mar 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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