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NCT01850160
Efficacy and Safety of the Fixed-dose Combination of Valsartan Plus Chlorthalidone Vs Valsartan or Chlorthalidone Alone in the Treatment of Arterial Hypertension, Open-label, Controlled, Randomized and Multicenter Trial
Phase 3 trial testing GROUP A: Valsartan plus Chlorthalidone in Hypertension in 124 participants. Completed in 1 May 2015.
1 March 2015
Quick facts
| Lead sponsor | Farma de Colombia SA |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 1 April 2013 |
| Primary completion | 1 March 2015 |
| Estimated completion | 1 May 2015 |
| Sites | 8 locations across Colombia, Ecuador |
Drugs / interventions tested
- GROUP A: Valsartan plus Chlorthalidone — full drug profile →
- GROUP B: Valsartan — full drug profile →
- GROUP C: Chlorthalidone — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
Farma de Colombia SA — full company profile →
Who can join
Adults 18 to 70, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Safety and Efficacy of the fixed-dose combination treatment with Valsartan plus Chlorthalidone
Time frame: 12 weeks
Efficacy and safety of a fixed-dose combination treatment of Valsartan plus Chlorthalidone Vs Valsartan or Chlorthalidone alone in the treatment of patients with arterial hypertension
Sponsor's own description
This trial is aimed to assess the efficacy and safety of a fixed-dose combination therapy with Valsartan and Chlorthalidone, Vs Valsartan or Chlorthalidone alone for treatment of adult patients with diagnosis of arterial hypertension.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Efficacy and Safety of Valsartan or Chlorthalidone vs. Combined Valsartan and Chlorthalidone in Patients With Mild to Moderate Hypertension: The VACLOR Study.
Manzur F, Rico A, Romero JD, Rodriguez-Martinez CE. · · 2018 · cited 2× · PMID 30202211 · DOI 10.1177/1179546818796482
Verify or expand the search:
- PubMed search for NCT01850160
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01850160 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Farma de Colombia SA
- Last refreshed: 25 January 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01850160.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing