A double-blind, randomized, multi-center active-controlled, parallel-group study comparing the combination of valsartan 320 mg plus hydrochlorothiazide 12.5 mg and valsartan 320 mg plus hydrochlorothiazide 25 mg to valsartan 320 mg in mild to moderate hypertensive patients not adequately controlled with valsartan 320 mg.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-001197-10-HU
• Date of registration: 31/08/2004
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals Corporation
• Public title: A double-blind, randomized, multi-center active-controlled, parallel-group study comparing the combination of valsartan 320 mg plus hydrochlorothiazide 12.5 mg and valsartan 320 mg plus hydrochlorothiazide 25 mg to valsartan 320 mg in mild to moderate hypertensive patients not adequately controlled with valsartan 320 mg.
• Scientific title: A double-blind, randomized, multi-center active-controlled, parallel-group study comparing the combination of valsartan 320 mg plus hydrochlorothiazide 12.5 mg and valsartan 320 mg plus hydrochlorothiazide 25 mg to valsartan 320 mg in mild to moderate hypertensive patients not adequately controlled with valsartan 320 mg.
• Date of first enrolment: 03/08/2004
• Target sample size: 2668
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001197-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Hungary

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female outpatients age between 18-80 years of age, inclusive
2. Diagnosed at enrollment (Visit 2) to be mild to moderate hypertensive with a MSDBP ?95 and <110 mmHg for non treated patients. Previously treated patients should have a MSDBP <110 mmHg at Visit 1 and a MSDBP ? 95 and <110 mmHg at Visit 2.
3. At Visit 3 all patients must have a MSDBP ? 90 mmHg and ? 110 mmHg..
4. Written informed consent to participate in the study prior to any study procedures
5. Ability to communicate and comply with all study requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Severe hypertension ( MSDBP ?110 mmHg and/or MSSBP ? 180 mmHg ).
2. Inability to discontinue all prior anti-hypertensive medications safely for a period of 2-4 weeks, as required by the protocol.
3. Female patients who are not either post-menopausal for one year or surgically sterile, or who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Hormonal contraceptive use is disallowed.
4. History of hypertensive encephalopathy or cerebrovascular accident within 1 year prior to Visit 1.
5. Known Keith-Wagener grade III or IV hypertensive retinopathy.
6. Transient ischemic cerebral attack, myocardial infarction, all types of revascularization procedures during the last 12 months prior to Visit 1.
7. Heart failure requiring treatment.
8. Second or third degree heart block without a pacemaker.
9. Concomitant refractory angina pectoris.
10. Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia or
11. Clinically significant valvular heart disease.
12. Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing’s disease, pheochromocytoma, polycystic kidney disease, etc.
13. Diabetes patients requiring insulin treatment
14. Type 2 diabetic patients who, in the opinion of the investigator, are not well controlled.
15. Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those anti-hypertensive medications requiring tapering down commencing at Visit 1.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Mild to moderate hypertension

Intervention(s)

Product Name: valsartan
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: Hydrochlorothiazide
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To demonstrate the blood pressure reduction effect of valsartan/HCTZ 320/25 mg o.d. or 320/12.5 mg o.d. in patients with mild to moderate hypertension not adequately controlled with valsartan 320 mg monotherapy o.d. (MSDBP =90 mmHg and ?110 mmHg at Visit 3) by testing the hypothesis that either valsartan/HCTZ 320/25 mg o.d. or valsartan/HCTZ 320/12.5 mg o.d. produces superior reduction in the mean sitting diastolic blood pressure (MSDPB) from baseline compared to valsartan 320 mg o.d alone

Secondary Objective: 1. Diastolic blood pressure reduction of valsartan/HCTZ 320/25 mg o.d. vs 320/12.5 mg o.d. in patients not adequately controlled with valsartan 320 mg monotherapy o.d. ( MSDBP =90 mmHg and ?110 mmHg at Visit 3)
2. Systolic BP reduction by valsartan/HCTZ 320/25 mg or valsartan/HCTZ 320/12.5 mg, in patients with mild to moderate hypertension not adequately controlled with valsartan 320 mg monotherapy
3. efficacy of valsartan/HCTZ 320/25 mg compared to 320/12.5 mg, in patients with mild to moderate hypertension not adequately controlled with valsartan 320 mg monotherapy, by testing the hypothesis that the combination of valsartan/HCTZ 320/25 mg produces superior reductions in MSSBP compared to the combination of valsartan/HCTZ 320/12.5 mg;
4. responder rates at the end of the study of these three treatments
5.relative tolerability and safety

Primary end point(s): The primary variable is the change from baseline in trough mean sitting diastolic blooding pressure (MSDBP) at the endpoint. MSDBP is defined as the average of available readings of the sitting diastolic blood pressure from one visit. If all three readings are missing at a particular visit, MSDBP will not be calculated. However, for the endpoint, the last post-baseline measurement during the double-blind period will be carried forward as the endpoint measurement.

Secondary ID(s)

CVAH631C2302