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Completed

NCT Number: NCT01001572

Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative site in Romainia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must give written informed consent
  • Male or female ages 18 or older and less than 86 years
  • Diagnosed as having essential diastolic hypertension, as follows:
  • Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and < 100 mmHg
  • At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP >=90 mmHg and <110 mmHg

Exclusion criteria

  • Severe hypertension
  • Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
  • Malignant hypertension
  • Administration of any agent indicated for the treatment of hypertension after Visit 1
  • Known moderate or malignant retinopathy.
  • Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
  • History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
  • History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
  • Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Valsartan/amlodipine 160/5 mg

Drug

Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.

Other names: Exforge® 160/5mg

Valsartan 160 mg

Drug

Valsartan 160 mg capsule taken orally once daily.

Other names: Diovan® 160mg

Placebo

Drug

1 capsule or tablet taken orally once daily

Primary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint

    Time frame: Baseline and Week 8

    Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.

Secondary outcomes

  1. Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint

    Time frame: Baseline and Week 8

    Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate

  2. Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint

    Time frame: Baseline and Week 8

    The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline.

  3. Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint

    Time frame: Week 8

    The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg.

  4. Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint

    Time frame: Week 8

    The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 26, 2009
Registry last updated
May 24, 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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