Clinical trial NCT00425373: Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Essential Hypertension
Keywords: Hypertension, Valsartan, Amlodipine, high blood pressure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-23
Enrollment: 1474
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.


Eligibility criteria: Inclusion criteria

* Patients with essential hypertension measured by electronic hemodynamometer. - - Patients must satisfy the following criteria.

  1. MSDBP \<110 mmHg and MSSBP \<180 mmHg at Visit 1
  2. MSDBP ≥ 90 mmHg and \< 110 mmHg and MSSBP \< 180 mmHg at Visit 2
  3. MSDBP ≥ 95 mmHg and \< 110 mmHg and MSSBP \< 180 mmHg at Visit 3
  4. The absolute difference in MSDBP between Visit 2 and 3 is ≤ 10 mmHg
* Male or female outpatients.
* Aged =\> 20 and =\< 80 years (at the time of signing informed consent).
* Patients who have written informed consent to participate in this study.

Exclusion criteria

* Pregnant women, nursing (lactating) mothers, women suspected of being pregnant, or women who wish to be pregnant during the study, women of child-bearing potential.
* Patients with secondary hypertension or suspected of having secondary hypertension.
* Patients with a history of malignant hypertension.
* Patients with an inability to completely discontinue all prior antihypertensive medications safely for a period of 12 weeks as required by the protocol.
* Patients with or with a history of any of the following diseases or signs: Cardiac disease, renal disease, cerebrovascular disorder
* Patients with a clinically significant allergy (asthma on pharmacotherapy, multi-drug allergy, or drug-induced or food-induced anaphylactic reactions).
* Patients hypersensitive to AII receptor antagonists, calcium channel blockers or dihydropyridine derivatives.
* Known moderate or malignant retinopathy.
* Patients with or with a history of pancreatitis. Patients with pancreatic injury, or evidence of impaired pancreatic function/injury within 12 months of Visit 1.
* Patients with any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
* Patients with volume depletion based on the investigator's or subinvestigator's clinical judgment using vital signs, skin turgor, moistness of mucous membrane and laboratory values.
* Patients who are found to have low Na and K (Na \<130 mEq/L, K \<3.3mEq/L) or high in these parameters (Na ≥ 152 mEq/L, K ≥ 5.2 mEq/L) by laboratory tests at Visit 1.
* Patients with type I diabetes mellitus on treatment with insulin, or patients with type II diabetes with poor glucose control defined as a glycosylated hemoglobin (HbA1c) \> 8.0% at Visit 1.
* Patients with or with a history of malignant tumors including leukemia and lymphoma, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases (except for localized basal cell carcinoma of the skin).
* Patients with any severe, life-threatening disease within the past 5 years. Patients with a history of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus.
* Any surgical or medical condition, which in the opinion of the investigator or subinvestigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirement of the study or completing the trial period.
* Patients who have with or with a history of drug or alcohol abuse within the last 2 years of Visit 1. Patients who have received other investigational product within 12 weeks of Visit 1.
* Any chronic inflammatory condition needing chronic anti-inflammatory drug therapy.
* Persons directly involved in the execution of this study.
* Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or subinvestigator.

Primary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
measure: Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
measure: Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
measure: Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)
timeFrame: Baseline to end of study (Week 8)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Sponsor GmbH
name: Novartis Japan
role: STUDY_CHAIR
References: